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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 K851227
Device Name THE ENDURO
Applicant
Wheel Ring, Inc.
175 Pine St.
Manchester,  CT  06040
Applicant Contact KENNETH B BOUCHARD
Correspondent
Wheel Ring, Inc.
175 Pine St.
Manchester,  CT  06040
Correspondent Contact KENNETH B BOUCHARD
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/26/1985
Decision Date 07/01/1985
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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