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510(k) K924224

OWENS BIOPSY FORCEPS by Owens Precision Systems, Inc. — Product Code HFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1994
Date Received
August 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Gynecological
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Owens Precision Systems, Inc.

  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K924485 — LAPAROSCOPY SET (March 9, 1994)

Other clearances for product code HFB

  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • K944444 — CIT BIOPSY PUNCHES (September 29, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (May 26, 1994)
  • K926595 — OWENS BIOPSY FORCEPS (May 25, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K926538 — TISCHLER BIOPSY FORCEPS (February 24, 1994)
  • K930036 — THOMAS MEDICAL BIOPSY FORCEPS (February 24, 1994)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)
  • K895303 — EVER-SHARP BIOPSY FORCEPS (January 16, 1990)