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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 K921512
Device Name ENTENDED LINE ACCESSORIES & CONNECTORS
Applicant
Intersurgical, Inc.
P.O. Box 642
Carriage Ln. Pl.
Cazenovia,  NY  13035
Applicant Contact THOMAS R GUNERMAN
Correspondent
Intersurgical, Inc.
P.O. Box 642
Carriage Ln. Pl.
Cazenovia,  NY  13035
Correspondent Contact THOMAS R GUNERMAN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received03/24/1992
Decision Date 06/17/1992
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
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