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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K954136
Device Name MATRIX MICROSON 410
Applicant
Matrix Biokinetics, Inc.
4208 Arcata Way, Unit C
North Las Vegas,  NV  89030
Applicant Contact DEBORAH SORGNARD
Correspondent
Matrix Biokinetics, Inc.
4208 Arcata Way, Unit C
North Las Vegas,  NV  89030
Correspondent Contact DEBORAH SORGNARD
Regulation Number890.5300
Classification Product Code
IMI  
Date Received09/01/1995
Decision Date 04/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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