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510(k) K841629

DRILL BIT by Plastafil, Inc. — Product Code HTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
April 19, 1984
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

Other clearances by Plastafil, Inc.

  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K841625 — HOOK (August 27, 1984)
  • K841626 — PUNCH (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841627 — MALLET (August 27, 1984)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)

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)
  • K915692 — CANNULATED DRILL BIT (January 16, 1992)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS (February 6, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K834229 — BONE PLUGGING TOOL (January 10, 1984)
  • K831712 — SURGICAL DRILL BITS (July 7, 1983)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)