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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K072534
Device Name BIO-MAT 2000
Applicant
RICHWAY INTL., INC.
1314 SOUTH KING ST., SUITE 520
HONOLULU,  HI  96814
Applicant Contact LEROY KLIMA
Correspondent
RICHWAY INTL., INC.
1314 SOUTH KING ST., SUITE 520
HONOLULU,  HI  96814
Correspondent Contact LEROY KLIMA
Regulation Number890.5740
Classification Product Code
IRT  
Date Received09/07/2007
Decision Date 02/08/2008
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
Predetermined Change
Control Plan Authorized		 No
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