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510(k) K904983

MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY by Meadox Surgimed, Inc. — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
November 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

Other clearances by Meadox Surgimed, Inc.

  • K944143 — MS CLASSIQUE BALLOON CATHETER (March 13, 1995)
  • K945061 — NOPROFILE OLBERT CATHETER SYSTEM (March 9, 1995)
  • K942382 — MS AMPLATZ EXTRA STIFF GUIDE WIRE (August 22, 1994)
  • K930201 — ACECUT SUTOMATIC BIOPSY SYSTEM (June 9, 1993)
  • 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)
  • 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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