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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Rebreathing, Radionuclide
510(k) Number K853056
Device Name RESPIR GARD-II FACE MASK CORRUGATED TUBING
Applicant
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Applicant Contact JOHN ADAMS
Correspondent
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Correspondent Contact JOHN ADAMS
Regulation Number892.1390
Classification Product Code
IYT  
Date Received07/19/1985
Decision Date 08/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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