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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 K974796
Device Name LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
Applicant
MEDISPEC, LTD.
19110 MONTGOMERY VILLAGE AVE.
SUITE 100
MONTGOMERY VILLAGE,  MD  20886
Applicant Contact AVNER SPECTOR
Correspondent
MEDISPEC, LTD.
19110 MONTGOMERY VILLAGE AVE.
SUITE 100
MONTGOMERY VILLAGE,  MD  20886
Correspondent Contact AVNER SPECTOR
Regulation Number876.4480
Classification Product Code
FFK  
Date Received12/22/1997
Decision Date 03/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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