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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flask, Tissue Culture
510(k) Number K870865
Device Name TISSUE CULTURE BAG
Applicant
American Fluoroseal Corp.
204 Stonegate Dr.
Silver Spring,  MD  20904
Applicant Contact CHARLES SOODAK
Correspondent
American Fluoroseal Corp.
204 Stonegate Dr.
Silver Spring,  MD  20904
Correspondent Contact CHARLES SOODAK
Regulation Number864.2240
Classification Product Code
KJA  
Date Received03/03/1987
Decision Date 03/30/1987
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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