FDA 510(k) Application Details - K130978

Device Classification Name

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510(K) Number K130978
Device Name ZTX ULTRASONIC DIATHERMY DEVICE
Applicant ZetrOZ INC
56 QUARRY ROAD
TRUMBULL, CT 06611 US
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Contact GEORGE K LEWIS, JR.
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Regulation Number

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Classification Product Code PFW
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Date Received 04/09/2013
Decision Date 11/06/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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