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510(k) K011618

CALGITROL AG SILVER ALGINATE WOUND DRESSING by Adri — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2002
Date Received
May 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Adri

  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K000054 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (March 13, 2000)
  • K963656 — FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING (November 12, 1996)
  • K940404 — ALGINATE FIBER TOPICAL WOUND DRESSING (May 4, 1994)
  • K870383 — ALGINATE WOOL FIBER (April 30, 1987)

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