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510(k) K924485

LAPAROSCOPY SET by Owens Precision Systems, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1994
Date Received
September 3, 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 Precision Systems, Inc.

  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K924224 — OWENS BIOPSY FORCEPS (February 4, 1994)

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