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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 other than applying therapeutic deep heat
510(k) Number K121702
Device Name ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
Original Applicant
ORTHO MEDICAL
200 homer ave.
ashland,  MA  01721
Original Contact david rothkopf
Regulation Number890.5290
Classification Product Code
ILX  
Date Received06/08/2012
Decision Date 05/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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