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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
Recalls CDRH Recalls
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