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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K162119
Device Name UreTron PF Series Probe
Applicant
MED-SONICS CORP.
4960 PITTSBURGH AVENUE, SUITE A
ERIE,  PA  16509
Applicant Contact JENNIFER RAUTINE
Correspondent
MED-SONICS CORP.
4960 PITTSBURGH AVENUE, SUITE A
ERIE,  PA  16509
Correspondent Contact JENNIFER RAUTINE
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/01/2016
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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