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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K981114
Device Name MICROCAP
Applicant
ORIDION MEDICAL LTD.
7 HAMARPE ST.
P.O. BOX 45025
JERUSALEM,  IL 91450
Applicant Contact SANFORD BROWN
Correspondent
ORIDION MEDICAL LTD.
7 HAMARPE ST.
P.O. BOX 45025
JERUSALEM,  IL 91450
Correspondent Contact SANFORD BROWN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/27/1998
Decision Date 06/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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