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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K141515
Device Name AED HYSTEROSCOPE AND ACCESSORIES
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 Number884.1690
Classification Product Code
HIH  
Date Received06/09/2014
Decision Date 01/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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