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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K953676
Device Name BREEZE DIGITAL INFLATION DEVICE
Applicant
Namic
Pruyns Island
Glens Falls,  NY  12801
Applicant Contact MARY MEAGHER RUBIN
Correspondent
Namic
Pruyns Island
Glens Falls,  NY  12801
Correspondent Contact MARY MEAGHER RUBIN
Regulation Number870.1650
Classification Product Code
MAV  
Date Received08/07/1995
Decision Date 03/29/1996
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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