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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, physical therapy, multi function
510(k) Number K140592
Device Name CERAGEM AUTOMATIC THERMAL MASSAGER
Applicant
Ceragem International Inc.
1468 Harwell Avenue
crofton,  MD  21114
Applicant Contact e.j. smith
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Ste 200
irvine,  CA  92620
Correspondent Contact priscilla chung
Regulation Number890.5880
Classification Product Code
JFB  
Date Received03/07/2014
Decision Date 12/17/2014
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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