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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 K022464
Device Name EQUILASE SYSTEM
Applicant
Equilasers, Inc.
3350 Scott Blvd.
Unit 5
Santa Clara,  CA  95054
Applicant Contact RICHARD C SAM
Correspondent
Equilasers, Inc.
3350 Scott Blvd.
Unit 5
Santa Clara,  CA  95054
Correspondent Contact RICHARD C SAM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/26/2002
Decision Date 11/21/2002
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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