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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 K844370
Device Name BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
Applicant
Precision Dynamics Corp.
Post Office Box 9043
Van Nuys,  CA  91409
Applicant Contact GINO FRANCO
Correspondent
Precision Dynamics Corp.
Post Office Box 9043
Van Nuys,  CA  91409
Correspondent Contact GINO FRANCO
Regulation Number866.2390
Classification Product Code
JSM  
Date Received11/13/1984
Decision Date 01/04/1985
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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