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510(k) K900822

HYDRO-SIL(TM) COATED GUIDEWIRES by National-Standard Medical Products — Product Code DOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1990
Date Received
February 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, Lead (Dedicated Instruments)
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
Submission Type

Other clearances by National-Standard Medical Products

  • K896605 — KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) (January 4, 1990)
  • K896606 — JACKSON FINE NEEDLE ASPIRATION SYSTEM (January 4, 1990)

Other clearances for product code DOX

  • K014195 — KAYAK HYDROPHILIC GUIDE WIRES (March 19, 2002)
  • K944226 — MSI PROCEDURE KIT (June 21, 1995)
  • K832030 — HEPARIN COATED STAINLESS STEEL/TEFLON (September 29, 1983)