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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 K932730
Device Name EXCEL'S EST-30 HO:YAG LASER SYSTEM
Applicant
Excel Tech. , Ltd.
45 Adams Ave.
Hauppauge,  NY  11788
Applicant Contact KEVIN G CHITTIM
Correspondent
Excel Tech. , Ltd.
45 Adams Ave.
Hauppauge,  NY  11788
Correspondent Contact KEVIN G CHITTIM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/07/1993
Decision Date 03/01/1994
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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