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510(k) K926596

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES by Owens Industries, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
September 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Owens Industries, Inc.

  • K926594 — OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES (June 6, 1994)
  • K926595 — OWENS BIOPSY FORCEPS (May 25, 1994)
  • K932796 — OWENS TROCAR (February 2, 1994)

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