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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, non-electric
510(k) Number K925392
Device Name BIOPSY FORCEPS
Applicant
ENDO-THERAPEUTICS, INC.
604-C PACKARD COURT
SAFETY HARBOR,  FL  34695
Applicant Contact JOHN G CHASE
Correspondent
ENDO-THERAPEUTICS, INC.
604-C PACKARD COURT
SAFETY HARBOR,  FL  34695
Correspondent Contact JOHN G CHASE
Regulation Number876.1075
Classification Product Code
FCL  
Subsequent Product Codes
BWH   KNW  
Date Received10/26/1992
Decision Date 11/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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