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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K102663
Device Name AED RESECTOSCOPE
Applicant
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
22134 SHERMAN WAY
CANOGA PARK,  CA  91303
Applicant Contact GAYLE BUTLER
Correspondent
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
22134 SHERMAN WAY
CANOGA PARK,  CA  91303
Correspondent Contact GAYLE BUTLER
Regulation Number876.1500
Classification Product Code
FJL  
Subsequent Product Codes
FAS   FDC  
Date Received09/15/2010
Decision Date 12/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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