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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 K862472
Device Name QUARTZ RODS TITANIUM RODS
Applicant
Quali-Med, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact RICK FOSTER
Correspondent
Quali-Med, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact RICK FOSTER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/30/1986
Decision Date 09/12/1986
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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