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510(k) K901369

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II by Sterling Drug, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1990
Date Received
March 23, 1990
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 Sterling Drug, Inc.

  • K896110 — BIOBRANE(R) II (November 28, 1989)
  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • K840260 — PERIOGRAF DURAPATITE 40-60 MESH (April 5, 1984)
  • K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
  • K820164 — EMPTY STERILE CARPUJECT (February 24, 1982)
  • K813257 — ALVEOGRAF DURAPATITE(18-40 MESH) (January 5, 1982)
  • K813070 — PERIOGRAF (November 20, 1981)
  • K780209 — DILUTION SPIKE (April 10, 1978)

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