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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stocking, medical support (to prevent pooling of blood in legs)
510(k) Number K092892
Device Name 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
Applicant
I-MING SANITARY MATERIALS CO., LTD.
101-10 DU TU LN., ER HSI RD.,
PEISHIH LI
HSIHU, CHANG HUA,  TW
Applicant Contact SARA HOU
Correspondent
I-MING SANITARY MATERIALS CO., LTD.
101-10 DU TU LN., ER HSI RD.,
PEISHIH LI
HSIHU, CHANG HUA,  TW
Correspondent Contact SARA HOU
Regulation Number880.5780
Classification Product Code
DWL  
Subsequent Product Code
JOW  
Date Received09/21/2009
Decision Date 08/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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