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510(k) K930201

ACECUT SUTOMATIC BIOPSY SYSTEM by Meadox Surgimed, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1993
Date Received
January 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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  • K911635 — MEADOX(R) SURGIMED(R) BIOPSY GUN II (June 20, 1991)
  • K905181 — NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY (March 6, 1991)
  • K904582 — QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE (February 25, 1991)
  • K904983 — MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY (January 30, 1991)
  • K902461 — MEADOX SURGIMED BIOPSY GUN AND NEEDLE (July 16, 1990)
  • K890926 — SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE (June 20, 1989)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)

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