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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
Model LBTK-M-I 1000
Device Name A-V FOOT PUMP
Original Applicant
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
rm 1706 yuesha, no. 128
songle rd, songjiang area
shanghai,  CH 201600
Original Contact doris dong
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/11/2012
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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