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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stationary ultrasonic diathermy device for use in applying therapeutic deep heat
510(k) Number K130978
Device Name ZTX ULTRASONIC DIATHERMY DEVICE
Applicant
ZetrOZ INC
56 QUARRY ROAD
TRUMBULL,  CT  06611
Applicant Contact GEORGE K LEWIS, JR.
Correspondent
ZetrOZ INC
56 QUARRY ROAD
TRUMBULL,  CT  06611
Correspondent Contact GEORGE K LEWIS, JR.
Regulation Number890.5300
Classification Product Code
PFW  
Date Received04/09/2013
Decision Date 11/06/2013
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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