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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 K000317
Device Name SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
Applicant
Tissue Medical Lasers, Inc.
4432 Anaheim Ave., NE
Albuquerque,  NM  87113
Applicant Contact DWIGHT ZURAWSKI
Correspondent
Tissue Medical Lasers, Inc.
4432 Anaheim Ave., NE
Albuquerque,  NM  87113
Correspondent Contact DWIGHT ZURAWSKI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/01/2000
Decision Date 10/27/2000
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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