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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 K950710
Device Name MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER
Applicant
Microquartz Medical, Inc.
4502-A N. 16th St.
Phoenix,  AZ  85016
Applicant Contact JOE D BROWN
Correspondent
Microquartz Medical, Inc.
4502-A N. 16th St.
Phoenix,  AZ  85016
Correspondent Contact JOE D BROWN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/13/1995
Decision Date 03/10/1995
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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