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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Circumcision
510(k) Number K902119
Device Name SAFEBRIS STERILE CIRCUMCISION KIT
Applicant
Kedumin Kits, Ltd.
P.O. Box 2273
Rehovot, Israel,  IL
Applicant Contact ORBACH, PH.D.
Correspondent
Kedumin Kits, Ltd.
P.O. Box 2273
Rehovot, Israel,  IL
Correspondent Contact ORBACH, PH.D.
Regulation Number884.4530
Classification Product Code
FHJ  
Date Received05/09/1990
Decision Date 11/05/1990
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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