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510(k) K904233

CONVATEC ABSORBENT BANDAGE by Convatec, A Division of E.R. Squibb & Sons — Product Code EXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
September 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

Other clearances by Convatec, A Division of E.R. Squibb & Sons

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  • K063271 — AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED AN (April 16, 2007)
  • K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING (June 21, 2002)
  • K990964 — SIGNADRESS DUODERM DRESSING (May 18, 1999)
  • K984388 — HA ABSORBENT WOUND DRESSING (March 3, 1999)
  • K980720 — NONWOVEN PAD (April 15, 1998)
  • K980382 — NON-WOVEN COMPRESS (March 9, 1998)
  • K974823 — NONWOVEN DRESSING (February 20, 1998)
  • K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (February 6, 1998)

Other clearances for product code EXE

  • K770982 — UNITED SKIN BARRIER (July 15, 1977)
  • K760927 — STOMA SHIELD ADAPTER (January 26, 1977)