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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Transport, Aerobic
510(k) Number K882580
Device Name MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
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 Number866.2900
Classification Product Code
JTW  
Date Received06/21/1988
Decision Date 07/08/1988
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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