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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Mirror
510(k) Number K862717
Device Name HAND MIRROR (ENDOSCOPE)
Applicant
Simpson/Basye, Inc.
430 Ayre St.
Wilmington,  DE  19804
Applicant Contact ROBERT BASYE
Correspondent
Simpson/Basye, Inc.
430 Ayre St.
Wilmington,  DE  19804
Correspondent Contact ROBERT BASYE
Regulation Number876.1500
Classification Product Code
GCO  
Date Received07/17/1986
Decision Date 07/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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