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LYU — Accessory, Surgical Apparel Class I

FDA Device Classification

Classification Details

Product Code
LYU
Device Class
Class I
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K011755strykerSTRYKER T4 HYTREL (R) TOGASJune 22, 2001
K965237copioumed intlNURSES BOUFFANT CAPAugust 27, 1997
K970988far east science and technology development coFAR-EAST BOUFFANT CAPSJuly 10, 1997
K964364instrument makarDISPOSABLE APRONFebruary 25, 1997
K961791depuyDEPUY DISPOSABLE FILTER/HOODAugust 9, 1996
K961454american medical mfgAMMI MAGNI-GUARDJuly 25, 1996
K945302sloanSLOAN STA-DRI PANT PROTECTORMarch 19, 1996
K954314stahmer weston scientificULTRAFIT LINERSDecember 28, 1995
K953089products for medicineI-SPOUSEOctober 16, 1995
K952303innovative outsourcing solutionsSPLASH ASSISTAugust 24, 1995
K942200thantex specialtiesISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSAugust 7, 1995
K944276sloanSLOAN STA-DRI BOOTLEG LEGGINGJuly 31, 1995
K944118sloanSLOAN STA-DRI SURGICAL JUMPSUITJuly 31, 1995
K946003intec industriesINTEC FULL FACE SHIELDJune 28, 1995
K951420alpha surgicalINCASE EXTENSIBLE BAG--NON-STERILEJune 8, 1995
K944763wells lamontCUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPApril 10, 1995
K945098op-d-op visor shieldsOP-D-OP IIFebruary 28, 1995
K942828instrument makarMAKAR FULL AND HALF FACE SHIELDFebruary 23, 1995
K943809white knight healthcareMONOGARD FACE SHIELDNovember 28, 1994
K940226derekduck industriesSHOE COVERSeptember 26, 1994