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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K121718
Device Name A-V FOOT PUMP
Applicant
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
RM 1706 YUESHA, NO. 128
SONGLE RD, SONGJIANG AREA
SHANGHAI,  CN 201600
Applicant Contact DORIS DONG
Correspondent
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
RM 1706 YUESHA, NO. 128
SONGLE RD, SONGJIANG AREA
SHANGHAI,  CN 201600
Correspondent Contact DORIS DONG
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/11/2012
Decision Date 08/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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