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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 K994010
Device Name INNOVAQUARTZ GENERAL SHAPE LASER FIBER
Applicant
Innovaquartz
4420 S. 32nd St.
Phoenix,  AZ  85040
Applicant Contact RANDY MCLELLAN
Correspondent
Innovaquartz
4420 S. 32nd St.
Phoenix,  AZ  85040
Correspondent Contact RANDY MCLELLAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/26/1999
Decision Date 12/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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