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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K852015
Device Name JYROCHAIR, MODEL SK-H
Applicant
Medco Products, Co., Inc.
31 Park Rd.
P.O. Box E
Tinton Falls,  NJ  07724
Applicant Contact RICHARD N LORD
Correspondent
Medco Products, Co., Inc.
31 Park Rd.
P.O. Box E
Tinton Falls,  NJ  07724
Correspondent Contact RICHARD N LORD
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/09/1985
Decision Date 07/19/1985
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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