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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 K110276
Device Name POWERPRESS UNIT
Applicant
HANURI DISTRIBUTION, INC
9601 OWENSMOUTH AVENUE
# 8
CHATSWORTH,  CA  91311
Applicant Contact JUNG HYUN MOON
Correspondent
HANURI DISTRIBUTION, INC
9601 OWENSMOUTH AVENUE
# 8
CHATSWORTH,  CA  91311
Correspondent Contact JUNG HYUN MOON
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
IRP  
Date Received01/31/2011
Decision Date 11/09/2011
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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