FDA 510(k) Applications for Medical Device Product Code "LRO"
(General Surgery Tray)

FDA 510(k) Number Applicant Device Name Decision Date
K023276 AMSINO INTERNATIONAL, INC. AMSINO TRACHEOSTOMY CARE TRAY 12/09/2002
K932221 ASSOCIATED MEDICAL PRODUCTS CO. NEUROLOGICAL OR CRANI TRAYS (PACKS) 03/19/1997
K030721 BALLARD MEDICAL PRODUCTS QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE 03/31/2003
K963443 CONTINENTAL MEDICAL LABORATORIES, INC. PROD. NO. 02-031 - LACERATION TRAY 10/17/1996
K964011 CUSTOMED, INC. SUCTION CATHETER TRAY PRODUCT NO. 900277 11/25/1996
K041080 D.I.R.R.A. S.R.L. SURGICAL DRAPE KIT - D.I.R.R.A. SRL 11/30/2004
K970187 GI SUPPLY RUNYON LARGE VOLUME PARACENTESIS KIT 02/14/1997
K963715 GRAND MEDICAL PRODUCTS DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY 11/27/1996
K963721 GRAND MEDICAL PRODUCTS SKIN SCRUB TRAY 11/27/1996
K953083 HOSPITAL LAUNDRY SERVICES HOSPITAL LAUNDRY SERVICES SURGICAL PACKS 05/14/1996
K961683 J.J. SKINNER, INC. JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY 05/10/1996
K212258 Medline Industries, Inc. Medline Cardiovascular Procedure Kit 12/03/2021
K213481 Medline Industries, Inc. Medline General Surgery Tray 05/24/2022
K962826 MEDLINE INDUSTRIES, INC. MEDLINE RADIOLOGY-DIAGNOSTIC KITS 09/16/1996
K970286 MEDLINE INDUSTRIES, INC. PRESBYTERIAN LINEN SERVICES SURGICAL PACKS 03/10/1997
K971061 OPPORTUNITY, INC. OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY 06/11/1997
K971062 OPPORTUNITY, INC. OPPORTUNITY INC. GENERAL PURPOSE TRAY 06/09/1997
K961863 TRI-MED, INC. PARACENTESIS TRAYS 05/28/1996
K964921 TRINITY LABORATORIES, INC. BASIC BIOPSY TRAY. DISPOSABLE, STERILE 01/22/1997
K965201 TRINITY LABORATORIES, INC. O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE 02/14/1997
K980137 WORLDWIDE MEDICAL TECHNOLOGIES, LLC WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY 01/30/1998


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