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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 K041465
Device Name SINON SN-L402 LIGHTWEIGHT WHEELCHAIR
Applicant
SINON CORPORATION
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW
Applicant Contact JEN KE-MIN
Correspondent
SINON CORPORATION
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/02/2004
Decision Date 07/23/2004
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
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