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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Mounting, Water Soluble
510(k) Number K781388
Device Name F.A. MOUNTING MEDIUM
Applicant
Flow Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Flow Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
KEQ  
Date Received08/10/1978
Decision Date 08/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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