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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,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
PRYM MEDICAL LTD.
117 AHUZAH ST.
RA'ANANNA,  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
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