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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 K880193
Device Name MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
Applicant
Sharplan Lasers, Inc.
1 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact STEPHEN DALTON
Correspondent
Sharplan Lasers, Inc.
1 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact STEPHEN DALTON
Regulation Number878.4810
Classification Product Code
LNK  
Date Received01/19/1988
Decision Date 04/14/1988
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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