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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 K871516
Device Name SL-100 ND:YAG LASER FOR UROLOGIC SURGERY
Applicant
MEDICAL ENERGY, INC.
8518 PUNTA LORA
PENSACOLA,  FL  32514
Applicant Contact DAVID P LEWING
Correspondent
MEDICAL ENERGY, INC.
8518 PUNTA LORA
PENSACOLA,  FL  32514
Correspondent Contact DAVID P LEWING
Regulation Number878.4810
Classification Product Code
LNK  
Date Received04/20/1987
Decision Date 07/09/1987
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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