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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 K070672
Device Name MASSAGE MATTRESS VM9100RM
Applicant
METEK GMBH
STAMMWEG 8
leinefelde,  DE 37327
Applicant Contact stefan ziegenfub
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
newton,  CT  06470
Correspondent Contact tamas borsai
Regulation Number890.5880
Classification Product Code
JFB  
Date Received03/12/2007
Decision Date 06/26/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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