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510(k) K894925

AMCATH URETERAL DILATORS MODELS 7100,7110,7120 by Intec Medical, Inc. — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1989
Date Received
August 2, 1989
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 Intec Medical, Inc.

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  • K903216 — THE GUIDER CORONARY GUIDING CATHETER (October 19, 1990)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY (October 16, 1990)
  • K903906 — PERCUTANEOUS CATHETER INTRODUCER KIT (September 26, 1990)
  • K900998 — INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE (August 14, 1990)
  • K901247 — TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES (July 31, 1990)
  • K860941 — DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (April 2, 1986)
  • K823271 — DISPOSABLE ADULT VO. VENTILATOR CIRCUIT (December 22, 1982)

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