FDA 510(k) Applications for Medical Device Product Code "HOZ"
(Sponge, Ophthalmic)

FDA 510(k) Number Applicant Device Name Decision Date
K091240 ALPHAMED INC. ALPHAMED SURGICAL SPEAR, MODEL 70-5000 10/23/2009
K972693 DEROYAL INDUSTRIES, INC. DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR 09/30/1997
K132796 HUIZHOU FORYOU MEDICAL DEVICES CO, LTD SUNTOUCH EYE SPEAR 10/30/2013
K990671 HURRICANE MEDICAL DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE 05/10/1999
K974313 HYDROFERA, LLC. HYDROFERA SURGICAL SPEAR 03/02/1998
K082460 LONGTEK SCIENTIFIC CO., LTD. CENEFOM PVA SURGICAL SPEAR 12/15/2008
K993883 M-PACT CORP. M-PACT CORNEAL LIGHT SHIELD 12/21/1999
K971832 M-PACT WORLDWIDE MANAGEMENT CORP. IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK 07/31/1997
K002279 MED-LOGICS, INC. ML EYE SPEAR, MODEL ML 27 ES 08/18/2000
K011191 MEDTRONIC XOMED, INC. MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES 06/26/2001
K130117 NETWORK MEDICAL PRODUCTS, LTD. NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS 10/29/2013
K982599 OPHTHALMIC SOLUTIONS, LLC. THE FREMSTAD RING 02/16/1999
K003842 PRESCOTT'S, INC. PRESCOTT'S SURGICAL SPEAR 04/13/2001
K964855 SHIPPERT MEDICAL TECHNOLOGIES CORP. EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD 03/04/1997
K012196 ULTRACELL MEDICAL TECHNOLOGIES, INC. ULTRACELL ABSORBENT STICK 08/24/2001
K972633 ULTRACELL MEDICAL TECHNOLOGIES, INC. ULTRACELL SUCTION SPONGE 12/17/1997
K990749 X-TECH MEDICAL, LLC. SOF-SUCTION FLUID EVACUATION SYSTEM 04/02/1999


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