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510(k) K915692

CANNULATED DRILL BIT by W.L. Gore & Associates, Inc. — Product Code HTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1992
Date Received
December 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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Other clearances for product code HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)
  • K930339 — REAMER BIT (August 6, 1993)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS (February 6, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K841629 — DRILL BIT (August 27, 1984)
  • K834229 — BONE PLUGGING TOOL (January 10, 1984)
  • K831712 — SURGICAL DRILL BITS (July 7, 1983)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)