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510(k) K821486

MICRO DRILLS by Spire Medical, Inc. — Product Code GFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1982
Date Received
May 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Spire Medical, Inc.

  • K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS. (July 2, 1982)
  • K821485 — DERMABRADERS (June 10, 1982)
  • K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)
  • K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)

Other clearances for product code GFG

  • K935225 — MITEK MODULAR DRILL BIT (April 7, 1994)
  • K821127 — KEY DRILL (June 3, 1982)