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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dish, Tissue Culture
510(k) Number K871483
Device Name TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES
Applicant
Isratech Marketing Corp.
200 Madison Ave.
New York,  NY  10016
Applicant Contact EFRAIM MARGOLIN
Correspondent
Isratech Marketing Corp.
200 Madison Ave.
New York,  NY  10016
Correspondent Contact EFRAIM MARGOLIN
Regulation Number864.2240
Classification Product Code
KIZ  
Date Received04/15/1987
Decision Date 04/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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