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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, Single Biochemical Test
510(k) Number K872691
Device Name IAFP UREA AGAR SLANT
Applicant
I.A.F. Production, Inc.
527, Boul. Des Prairies
Laval, Que. H7n-423,  CA
Applicant Contact FRANCOIS MORIN
Correspondent
I.A.F. Production, Inc.
527, Boul. Des Prairies
Laval, Que. H7n-423,  CA
Correspondent Contact FRANCOIS MORIN
Regulation Number866.2320
Classification Product Code
JSF  
Date Received07/07/1987
Decision Date 08/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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