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510(k) K924755

CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION by Convatec, A Division of E.R. Squibb & Sons — Product Code EXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1993
Date Received
September 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Paste-On For Incontinence, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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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 EXI

  • K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH (August 28, 1997)
  • K970443 — HOLLISTER RETRACTED PENIS POUCH (February 25, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K931277 — HOLLISTER PREMIUM URINE COLLECTOR (June 23, 1993)
  • K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (February 5, 1992)
  • K915616 — URIHESIVE STRIP (January 23, 1992)