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FRL — Fiber, Medical, Absorbent Class I

FDA Device Classification

Classification Details

Product Code
FRL
Device Class
Class I
Regulation Number
880.5300
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K121898quick-med technologiesSTAY FRESH SKIN FOLD MANAGEMENT TEXTILEMay 24, 2013
K110715milliken healthcare productsINTERDRY SILVERNovember 4, 2011
K061615milliken chemicalINTERDRY TEXTILE WITH SILVERDecember 22, 2006
K931626carapaceCARAPACE STERILE COTTON BALLSDecember 2, 1993
K914081icn pharmaceuticalsICAN COTTON RAYON BALLSOctober 9, 1991
K811990associated medical productsTRACH CLEANING TRAYJuly 27, 1981
K810242american hospital supplyUTENSIL & PROCEDURE TRAYSApril 15, 1981
K800277medspecMEDSPEC RAYON BALLSMarch 12, 1980
K800248medical engineeringSURGITEK FOERSTER FACE LIFT BANDAGEFebruary 19, 1980
K800249medical engineeringSURGITEK FOERSTER MAMMARY BANDAGEFebruary 19, 1980
K792295american hospital supplySORBIESDecember 20, 1979
K792294american hospital supplyBREAST PADDecember 11, 1979
K791167dexideDEXIDE DISPOSABLE PREP PADAugust 3, 1979
K780974urolBACILLUS PUMILUSJuly 27, 1978
K771712shield laboratoriesCATHETER DRESSING CHANCE SETOctober 13, 1977
K771551jelco laboratoriesI.V. PREP & CARE KITOctober 4, 1977
K770853stat medicalSTERILE COTTONMay 23, 1977
K770588american hospital supplyCOTTON BALL KITMay 23, 1977
K761099will rossDOVER HYPERALIMENTATION DRESSING CHNG KTJanuary 28, 1977