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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K883563
Device Name SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS
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
GEX  
Date Received08/19/1988
Decision Date 09/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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