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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name diathermy, shortwave, for use in applying therapeutic deep heat
510(k) Number K121123
Device Name BIOFUSIONARY BEBE
Original Applicant
ROCKY MOUNTAIN BIOSYSTEMS, INC.
3930 youngfield street
wheat ridge,  CO  80033
Original Contact amy benedict
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received04/13/2012
Decision Date 03/10/2014
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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