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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K984481
Device Name EXHALATION VALVE
Applicant
INTERSURGICAL, INC.
417 ELECTRONICS PKWY.
LIVERPOOL,  NY  13088
Applicant Contact THOMAS R GUNERMAN
Correspondent
INTERSURGICAL, INC.
417 ELECTRONICS PKWY.
LIVERPOOL,  NY  13088
Correspondent Contact THOMAS R GUNERMAN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/16/1998
Decision Date 01/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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