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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K974515
Device Name ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
Applicant
Endolap, Inc.
3012 Mercy Dr.
Orlando,  FL  32808
Applicant Contact TONY GILSTRAP
Correspondent
Endolap, Inc.
3012 Mercy Dr.
Orlando,  FL  32808
Correspondent Contact TONY GILSTRAP
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
FDC  
Date Received12/02/1997
Decision Date 12/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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