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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, muscle, powered
510(k) Number K882386
Device Name AGAR 3K NEUROMUSCULAR STIMULATOR
Applicant
SOLCOOR, INC.
8150 leesburg pike, ste.700
vienna,  VA  22180
Applicant Contact barbara a marsden
Correspondent
SOLCOOR, INC.
8150 leesburg pike, ste.700
vienna,  VA  22180
Correspodent Contact barbara a marsden
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/10/1988
Decision Date 10/18/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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