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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K974139
Device Name LQUET CANNULA/TROCAR SYSTEM
Applicant
Lifequest Endoscopic Technologies, Inc.
12961 Park Central, Suite 1300
San Antonio,  TX  78216
Applicant Contact JEFFREY SCOTT
Correspondent
Lifequest Endoscopic Technologies, Inc.
12961 Park Central, Suite 1300
San Antonio,  TX  78216
Correspondent Contact JEFFREY SCOTT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/03/1997
Decision Date 01/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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