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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K990949
Device Name CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
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 Number868.5260
Classification Product Code
CAH  
Date Received03/22/1999
Decision Date 06/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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