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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
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