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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 K010704
Device Name DORNIR LC-1 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 Received03/09/2001
Decision Date 04/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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