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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 K961838
Device Name RESPIRGARD II, SPIROGARD
Applicant
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Applicant Contact TOM DIELMANN
Correspondent
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Correspondent Contact TOM DIELMANN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/13/1996
Decision Date 10/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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