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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mold, Vaginal
510(k) Number K920838
Device Name MEDSURG CIRCUMCISION TRAY
Applicant
Medsurg Industries, Inc.
251 Exchange Place
Herndon,  VA  20170 -4822
Applicant Contact THOMAS BONNER
Correspondent
Medsurg Industries, Inc.
251 Exchange Place
Herndon,  VA  20170 -4822
Correspondent Contact THOMAS BONNER
Regulation Number884.3900
Classification Product Code
HFK  
Date Received02/24/1992
Decision Date 10/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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