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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 K922535
Device Name THE TERMINATOR
Applicant
Top End Wheelchair Sports, Inc.
6551 44th St. N., #5002
Pinellas Park,  FL  34665
Applicant Contact CAROL PETERSON
Correspondent
Top End Wheelchair Sports, Inc.
6551 44th St. N., #5002
Pinellas Park,  FL  34665
Correspondent Contact CAROL PETERSON
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/28/1992
Decision Date 07/24/1992
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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