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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K000888
Device Name SANSIBAR CPAP SYSTEM
Applicant
Prym Medical , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Prym Medical , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/20/2000
Decision Date 08/15/2000
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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