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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K911425
Device Name ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
Applicant
Intersurgical, Inc.
P.O. Box 642
Carriage Lane Place
Cazenovia,  NY  13035 -0642
Applicant Contact THOMAS R GUNERMAN
Correspondent
Intersurgical, Inc.
P.O. Box 642
Carriage Lane Place
Cazenovia,  NY  13035 -0642
Correspondent Contact THOMAS R GUNERMAN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received02/05/1991
Decision Date 06/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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