KOZ — Beads, Hydrophilic, For Wound Exudate Absorption Class I

FDA Device Classification

Classification Details

Product Code
KOZ
Device Class
Class I
Regulation Number
878.4018
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K905206hollisterINCARE PINSITE DRESSINGApril 12, 1991
K905688beiersdorfCUTINOVA HYDROApril 1, 1991
K905069perstorp ab c/o robert joel slomoffIODOSORB GELJanuary 31, 1991
K904604fountain pharmaceuticalsREDI-RELEASE ABSORBENT DRESSINGJanuary 7, 1991
K896828johnson and johnson internationalBIOCLUSIVE(R) ABSORBENT DRESSINGNovember 21, 1990
K903645convatec, a division of e.r. squibb and sonsDERMASORB WOUND CONTACT LAYER DRESSINGNovember 21, 1990
K904412smith and nephew unitedALLEVYN DRESSING CLAIMS CHANGEOctober 23, 1990
K901876smith and nephew unitedINTRASITE CAVITY WOUND DRESSING (LABEL REVISION)June 28, 1990
K896176controlled therapeuticsEXUSORB(TM) DRY/WET DRESSINGNovember 24, 1989
K895354smith and nephew unitedINTRASITE CAVITY WOUND DRESSINGNovember 7, 1989
K874552marion laboratoriesENVISAN PADJanuary 22, 1988
K872453pharmaciaDEBRISAN ABSORBENT PADJanuary 14, 1988
K874553marion laboratoriesENVISAN PASTEDecember 18, 1987
K872117interworldDEXTRANOMERJuly 24, 1987
K870941american pharmaseal div. ahscPHARMASEAL WOUND CARE DRESSING PADMarch 27, 1987
K870559perstorp ab c/o robert joel slomoffIODOSORB POWDERMarch 20, 1987
K844625biporeBIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLYJanuary 16, 1985
K834343coloplastCOMFEEL POWDERNovember 8, 1984
K820160hollisterHOLLISTER WOUND EXUDATE ABSORBERApril 21, 1982
K800737pharmaseal laboratoriesDEBRISAN (DEXTRANOMER) PASTEAugust 4, 1980