FDA 510(k) Applications for Medical Device Product Code "MSH"
(Respirator,Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K063023 3M COMPANY 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 02/23/2007
K121069 3M COMPANY 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 02/11/2013
K171116 3M Health Care 3MÖ VFlexÖ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S 08/10/2017
K041855 AEARO CO. PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S 11/10/2004
K072359 AEARO COMPANY AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C 11/08/2007
K070168 AEARO COMPANY N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C 04/18/2007
K063013 AEARO COMPANY PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S 12/01/2006
K092824 ALPHAPROTECH, INC. N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 10/21/2009
K070692 DUKAL CORPORATION DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK 05/30/2007
K080827 HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 04/04/2008
K051182 INOVEL LLC INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS 05/19/2005
K042267 INOVEL LLC INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP 09/30/2004
K061859 INOVEL LLC INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS 07/12/2006
K062665 INOVEL LLC INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS 10/24/2006
K063747 INOVEL LLC INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A 01/12/2007
K050193 LOUIS M. GERSON CO., INC. GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR 04/11/2005
K960778 LOUIS M. GERSON CO., INC. ISOLAIR APR TYPE N95 05/09/1996
K061375 LOUIS M. GERSON CO., INC. RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 11/17/2006
K020474 MAKRITE INDUSTRIES, INC. MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 07/23/2002
K172963 Master & Frank Enterprise Co., Ltd Master-Frank N95 Particulate Respirator 04/04/2018
K062663 MOLDEX/METRIC, INC. MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS 10/11/2006
K102173 MOLDEX/METRIC, INC. MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 09/13/2010
K102923 MOLNLYCKE HEALTHCARE BARRIER N95 PARTICULATE RESPIRATOR 11/19/2010
K141876 PASTURE PHARMA PTE LTD Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator 10/28/2015
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 10/06/2010
K100139 SAFELIFE CORP. SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 05/04/2010
K160271 SAN-M PACKAGE CO., LTD. N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 07/15/2016
K090131 SHANGHAI DASHENG HEALTH PRODUCTS DS N95 SURGICAL MASKS AND FLAT SURGICAL 04/27/2009
K063334 SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. SHANGHAI GANGHAI MODEL GIKO 1400 12/08/2006
K072067 SHUENN BAO SHING CORPORATION N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 01/08/2008
K070782 SURVIVAIR RESPIRATORS, LLC WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F 04/11/2007
K070139 SURVIVAIR, INC. WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 03/02/2007
K970448 TECNOL MEDICAL PRODUCTS, INC. PCM 2000; ISOLAIR APR MODEL 2735 04/30/1997
K974068 TECNOL MEDICAL PRODUCTS, INC. PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL 12/22/1997


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