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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 K121026
Device Name FLO-GUARD BREATHING FILTER
Applicant
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool,  NY  13088
Applicant Contact michael zalewski
Correspondent
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool,  NY  13088
Correspodent Contact michael zalewski
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/04/2012
Decision Date 11/02/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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