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510(k) K870882

45 DEGREE SHAVER by Bowen & Company, Inc. — Product Code HTZ

K870882 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "45 DEGREE SHAVER". The FDA issued a decision of Substantially Equivalent on March 23, 1987. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Bowen & Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1987
Date Received
March 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
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)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)
  • K863146 — BOWEN SUTURE PASSER (September 5, 1986)
  • K863147 — GLENOID DRILL (September 5, 1986)

Other clearances for product code HTZ

  • K933933 — CEBOPLANE (April 15, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K853678 — KAMBIN SPINAL INSTRUMENT SET (September 24, 1985)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K841975 — ROSETTE KNIFE 4MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources