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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 K933707
Device Name CAPNODIG
Applicant
Spegas Industries, Ltd.
Har Hotzvim Industrial Park
P.O.Box 23650ndusrial Park
Jerusalem,  IL 91235
Applicant Contact SANFORD BROWN
Correspondent
Spegas Industries, Ltd.
Har Hotzvim Industrial Park
P.O.Box 23650ndusrial Park
Jerusalem,  IL 91235
Correspondent Contact SANFORD BROWN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/30/1993
Decision Date 10/27/1993
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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