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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K843688
Device Name KARECO INT'L WHEELCHAIR
Applicant
Kareco Intl., Inc.
1a Colony Rd.
Jersey City,  NJ  07305
Applicant Contact KEVIN J O'NEIL
Correspondent
Kareco Intl., Inc.
1a Colony Rd.
Jersey City,  NJ  07305
Correspondent Contact KEVIN J O'NEIL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/19/1984
Decision Date 11/23/1984
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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