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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 K915169
Device Name EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM
Applicant
Excel Tech. , Ltd.
101-2 Colin Dr.
Holbrook,  NY  11741
Applicant Contact RAMA RAO
Correspondent
Excel Tech. , Ltd.
101-2 Colin Dr.
Holbrook,  NY  11741
Correspondent Contact RAMA RAO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/15/1991
Decision Date 04/02/1992
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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