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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K894662
Device Name TEST ONE
Applicant
Primed Products, Inc.
808 Pershing Dr. Suite 104
Silver Spring,  MD  20910
Applicant Contact LINDA GORVETT
Correspondent
Primed Products, Inc.
808 Pershing Dr. Suite 104
Silver Spring,  MD  20910
Correspondent Contact LINDA GORVETT
Regulation Number890.1925
Classification Product Code
IKK  
Date Received07/24/1989
Decision Date 12/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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