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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 K050691
Device Name R. POON MEDICAL PRODUCTS WHEELCHAIRS
Applicant
R. Poon Medical Products Co., Ltd.
10 Newton Place
Hauppauge,  NY  11788
Applicant Contact RICHARD GRAVER
Correspondent
R. Poon Medical Products Co., Ltd.
10 Newton Place
Hauppauge,  NY  11788
Correspondent Contact RICHARD GRAVER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/17/2005
Decision Date 04/21/2005
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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