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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Selective And Differential
510(k) Number K974428
Device Name DIPSTREAK
Applicant
Novamed , Ltd.
28 Pierre Koenig St.,
Talpiot Industrial Area
Jerusalem,  IL 93469
Applicant Contact GERALD M SLUTZKY
Correspondent
Novamed , Ltd.
28 Pierre Koenig St.,
Talpiot Industrial Area
Jerusalem,  IL 93469
Correspondent Contact GERALD M SLUTZKY
Regulation Number866.2360
Classification Product Code
JSI  
Date Received11/24/1997
Decision Date 07/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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