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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 K110246
FOIA Releasable 510(k) K110246
Device Name MEDISIZE RED AND MEDISIZE BLUE
Applicant
Qserve America, Inc.
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
Qserve America, Inc.
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received01/27/2011
Decision Date 11/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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