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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 K910114
Device Name OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE
Applicant
Xintec Corporation
900 Alice St.
Oakland,  CA  94607
Applicant Contact MARILYN M CHOU
Correspondent
Xintec Corporation
900 Alice St.
Oakland,  CA  94607
Correspondent Contact MARILYN M CHOU
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/10/1991
Decision Date 04/09/1991
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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