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510(k) K853601

MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP by Bowen & Company, Inc. — Product Code GAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
August 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Bowen & Company, Inc.

  • K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER (April 4, 1990)
  • K896538 — DISPOSABLE 45 DEGREE SHAVER (December 6, 1989)
  • K873766 — STERNAL POWER AWL (November 14, 1988)
  • K872098 — CREMEEN ALVEOLAR BONE CALIPER (July 31, 1987)
  • K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE (June 8, 1987)
  • K870881 — LOOSE BODY GRASPERS (March 23, 1987)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K863146 — BOWEN SUTURE PASSER (September 5, 1986)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)

Other clearances for product code GAC

  • K884473 — RUBIN BONE PLANER W/REPLACEABLE BLADE (December 9, 1988)