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510(k) K854726

MEDI-WIPES UNITED ANTISEPTIC SKIN PREP by Pfizer, Inc. — Product Code EXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1986
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K850403 — MEC DISTAL FEMORAL BOLT (July 15, 1985)
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  • K850840 — HOWMEDICA THREADED ACETABULAR COMPONENT (July 15, 1985)
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  • K851971 — SERIES 7000/HOLTER RECORDER (June 20, 1985)

Other clearances for product code EXB

  • K252140 — Heylo™ System (October 6, 2025)
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  • K140938 — OSTOM-I ALERT (October 10, 2014)
  • K922730 — LAKE OSTOMY CARE SET (December 30, 1993)
  • K882878 — ODOR-END EMERGENCY CLEAN UP POWDER (December 8, 1988)
  • K881636 — CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (July 13, 1988)
  • K880306 — EMERGENCY-CLEAN UP(TM) ECP (May 20, 1988)
  • K872294 — COMBINATION NITE DRAINAGE UNIT (December 29, 1987)
  • K873929 — 'CATCH-IT' OR FECAL CONTAINMENT DEVICE (December 3, 1987)
  • K871526 — ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (October 13, 1987)