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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
Original Applicant
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool,  NY  13088
Original 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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