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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nasopharyngeal
510(k) Number K851082
Device Name V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
Applicant
American V. Mueller
6600 W. Touhy
Chicago,  IL  60648
Applicant Contact MATHEW NOWLAND
Correspondent
American V. Mueller
6600 W. Touhy
Chicago,  IL  60648
Correspondent Contact MATHEW NOWLAND
Regulation Number874.4175
Classification Product Code
ENW  
Date Received03/18/1985
Decision Date 07/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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