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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 K954376
Device Name MUSTANG
Applicant
Temco, Inc.
400 Rabro Dr. E.
Hauppauge,  NY  11788
Applicant Contact FRED LEONARD
Correspondent
Temco, Inc.
400 Rabro Dr. E.
Hauppauge,  NY  11788
Correspondent Contact FRED LEONARD
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/19/1995
Decision Date 12/08/1995
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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