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510(k) K871628

PALEX (R) OSTOMY by Industrias Palex C/O Dma Med-Chem Corp. — Product Code EXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1987
Date Received
April 27, 1987
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

Other clearances by Industrias Palex C/O Dma Med-Chem Corp.

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  • K920366 — ULCUFLEX HYDROCOLOID POWDER (March 26, 1992)
  • K920367 — ULCUFLEX HYDROCULLOID DRESSING (March 26, 1992)

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  • 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)