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510(k) K813257

ALVEOGRAF DURAPATITE(18-40 MESH) by Sterling Drug, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1982
Date Received
November 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Sterling Drug, Inc.

  • K901369 — GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (June 5, 1990)
  • 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)
  • K820164 — EMPTY STERILE CARPUJECT (February 24, 1982)
  • K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
  • K813070 — PERIOGRAF (November 20, 1981)
  • K780209 — DILUTION SPIKE (April 10, 1978)

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