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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, biopsy, electric
510(k) Number K090796
Device Name MULTI-BITE HOT BIOPSY FORCEPS
Applicant
ENDO-THERAPEUTICS, INC.
15251 ROOSEVELT BLVD.
SUITE 204
CLEARWATER,  FL  33760
Applicant Contact MARK R WADDELL
Correspondent
ENDO-THERAPEUTICS, INC.
15251 ROOSEVELT BLVD.
SUITE 204
CLEARWATER,  FL  33760
Correspondent Contact MARK R WADDELL
Regulation Number876.4300
Classification Product Code
KGE  
Date Received03/24/2009
Decision Date 11/25/2009
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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