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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 K971404
Device Name SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER
Applicant
Schwartz Electro-Optics, Inc.
3404 N. Blossom Trail
Orlando,  FL  32804
Applicant Contact TIMOTHY J SHEA
Correspondent
Schwartz Electro-Optics, Inc.
3404 N. Blossom Trail
Orlando,  FL  32804
Correspondent Contact TIMOTHY J SHEA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/16/1997
Decision Date 07/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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