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510(k) K003134

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING by Adri/Technam — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2000
Date Received
October 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Adri/Technam

  • K941176 — ALGINATE FIBER (July 28, 1994)
  • K914779 — ALGINATE FIBER (December 4, 1991)

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