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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, External Body, Negative Pressure, Adult (Cuirass)
510(k) Number K893213
Device Name EASY BREATHER MODEL 100
Applicant
Progressive Productions , Ltd.
70 Archwood Dr.
Mohrsville,  PA  19541
Applicant Contact GENEVIEVE M BOGUSKY
Correspondent
Progressive Productions , Ltd.
70 Archwood Dr.
Mohrsville,  PA  19541
Correspondent Contact GENEVIEVE M BOGUSKY
Regulation Number868.5935
Classification Product Code
BYT  
Date Received04/27/1989
Decision Date 08/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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