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510(k) K802463

MICRO-SURGICAL POWER INSTRUMENT SYSTEM by Spire Medical, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 9, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Spire Medical, Inc.

  • K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS. (July 2, 1982)
  • K821485 — DERMABRADERS (June 10, 1982)
  • K821486 — MICRO DRILLS (June 9, 1982)
  • K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM (October 31, 1980)

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