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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K951722
Device Name PERCEPTOR COMPENSATOR MORSE MANIFOLD
Applicant
Namic
Pruyns Island
Glens Falls,  NY  12801
Applicant Contact MARY M RUBIN
Correspondent
Namic
Pruyns Island
Glens Falls,  NY  12801
Correspondent Contact MARY M RUBIN
Regulation Number870.2850
Classification Product Code
DRS  
Date Received04/14/1995
Decision Date 03/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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