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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 K031026
Device Name ETI BIPOLAR HEMOSTATIC PROBE
Applicant
ENDO-THERAPEUTICS, INC.
1183 CEDAR ST.
SAFETY HARBOR,  FL  34695 -2908
Applicant Contact TODD ADKISSON
Correspondent
ENDO-THERAPEUTICS, INC.
1183 CEDAR ST.
SAFETY HARBOR,  FL  34695 -2908
Correspondent Contact TODD ADKISSON
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/31/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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