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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 K855100
Device Name S.L.T. CONTACT LASER SYSTEM
Applicant
SURGICAL LASER TECHNOLOGIES, INC.
250 E 5TH ST. SUITE 1500
COLUMBIA PLAZA BLDG.
CINCINNATI,  OH  45202
Applicant Contact RICHARD L STUDER
Correspondent
SURGICAL LASER TECHNOLOGIES, INC.
250 E 5TH ST. SUITE 1500
COLUMBIA PLAZA BLDG.
CINCINNATI,  OH  45202
Correspondent Contact RICHARD L STUDER
Regulation Number878.4810
Classification Product Code
LNK  
Date Received12/23/1985
Decision Date 02/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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