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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 K981627
Device Name PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)
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 Received05/07/1998
Decision Date 07/31/1998
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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