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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 K895178
Device Name TECHNOMED PULSOLITH LASER SYSTEM
Applicant
TEKNOMED, INC.
NORTH WOODS BUSINESS PARK
99 ROSEWOOD DRIVE, SUITE 140
DANVERS,  MA  01923
Applicant Contact RICHARD HUNTER
Correspondent
TEKNOMED, INC.
NORTH WOODS BUSINESS PARK
99 ROSEWOOD DRIVE, SUITE 140
DANVERS,  MA  01923
Correspondent Contact RICHARD HUNTER
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/10/1989
Decision Date 10/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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