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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K871511
Device Name SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
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 Number874.4500
Classification Product Code
LLO  
Date Received04/20/1987
Decision Date 07/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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