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510(k) K931182

VESITEC DRILL GUIDE by Vesitec Medical, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1993
Date Received
March 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Vesitec Medical, Inc.

  • K932925 — BONE ANCHOR FOR SOFT TISSUE ATTACHMENT (April 26, 1994)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)

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