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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K905120
Device Name SAF FIXATIVE
Applicant
Gibson Laboratories, Inc.
1040 Manchester St.
Lexington,  KY  40508
Applicant Contact CECIL GIBSON
Correspondent
Gibson Laboratories, Inc.
1040 Manchester St.
Lexington,  KY  40508
Correspondent Contact CECIL GIBSON
Regulation Number866.2900
Classification Product Code
LIO  
Date Received11/14/1990
Decision Date 12/17/1990
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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