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510(k) K933670

BIOPSY PUNCH, SURGICAL by Byron Medical — Product Code EME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
July 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Biopsy, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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Other clearances for product code EME

  • K911285 — PULPDENT POLYAMIDE DENTIN LINER (October 9, 1991)
  • K884740 — EURO-MED LIGHT TOUCH BIOPSY PUNCH (March 6, 1989)