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510(k) K920367

ULCUFLEX HYDROCULLOID DRESSING by Industrias Palex C/O Dma Med-Chem Corp. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1992
Date Received
January 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

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

  • K920740 — EPISENSOR PLUS (March 7, 1994)
  • K920368 — ULCUFLEX HYDROCOLLOID PASTE (March 26, 1992)
  • K920366 — ULCUFLEX HYDROCOLOID POWDER (March 26, 1992)
  • K871628 — PALEX (R) OSTOMY (July 8, 1987)

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