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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 K981421
Device Name TC SERIES (RECLINER)
Applicant
Get A Life-Give A Living Plus Kids Project, Inc.
6561 44th St. N.
Pinellas Park,  FL  33781
Applicant Contact EUGENE M NAVES
Correspondent
Get A Life-Give A Living Plus Kids Project, Inc.
6561 44th St. N.
Pinellas Park,  FL  33781
Correspondent Contact EUGENE M NAVES
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/20/1998
Decision Date 06/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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