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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K945949
Device Name KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]
Applicant
Vlm Surgical, Inc.
1694 E. Mcandrews Rd.
Medford,  OR  97504
Applicant Contact V J KILEJIAN
Correspondent
Vlm Surgical, Inc.
1694 E. Mcandrews Rd.
Medford,  OR  97504
Correspondent Contact V J KILEJIAN
Regulation Number884.4530
Classification Product Code
HFX  
Date Received12/06/1994
Decision Date 07/25/1995
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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