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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, Non-Propagating Transport
510(k) Number K863164
Device Name AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
Applicant
Precision Dynamics Corp.
13880 Del Sur St.
San Fernando,  CA  91340
Applicant Contact GINO FRANCO
Correspondent
Precision Dynamics Corp.
13880 Del Sur St.
San Fernando,  CA  91340
Correspondent Contact GINO FRANCO
Regulation Number866.2390
Classification Product Code
JSM  
Date Received08/18/1986
Decision Date 08/27/1986
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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