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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K050264
Device Name STEALTH PRODUCTS SEATING SYSTEM
Applicant
Stealth Products
5905 Fawn Ln.
Cleveland,  OH  44141
Applicant Contact EDWARD A KROLL
Correspondent
Stealth Products
5905 Fawn Ln.
Cleveland,  OH  44141
Correspondent Contact EDWARD A KROLL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/04/2005
Decision Date 02/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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