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510(k) Premarket Notification Database

Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) NumberK820430
Device NameDIATHERMIC SNARES
Applicant  
AMERICAN ENDOSCOPY, INC.
Contact
Regulation Number876.4300
Classification Product Code
KNS
Subsequent Product Code
FDI
Date Received02/17/1982
Decision Date 04/08/1982
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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