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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent/Device, Inoculum Calibration
510(k) Number K820299
Device Name PROMPT INOCULATION SYSTEM
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number866.1640
Classification Product Code
LIE  
Date Received02/04/1982
Decision Date 03/15/1982
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
Recalls CDRH Recalls
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