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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K925395
Device Name TECHNOMED PULSOLITH 4000 LASER SYSTEM
Applicant
Teknomed, Inc.
North Woods Business Park
99 Rosewood Dr., Suite 140
Danvers,  MA  01923
Applicant Contact JEAN-LUC BOULNOIS
Correspondent
Teknomed, Inc.
North Woods Business Park
99 Rosewood Dr., Suite 140
Danvers,  MA  01923
Correspondent Contact JEAN-LUC BOULNOIS
Regulation Number878.4810
Classification Product Code
LNK  
Date Received10/26/1992
Decision Date 05/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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