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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K011787
Device Name PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
Applicant
Vidamed, Inc.
46107 Landing Pkwy.
Fremont,  CA  94538
Applicant Contact YI CHEN
Correspondent
Vidamed, Inc.
46107 Landing Pkwy.
Fremont,  CA  94538
Correspondent Contact YI CHEN
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received06/08/2001
Decision Date 07/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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