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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 K010867
Device Name KILEJIAN CIRCUMCISOR
Applicant
Iris Surgical, LLC
446 Arricola Ave.
St.Augustine,  FL  32080
Applicant Contact V. JOHN KILEJIAN
Correspondent
Iris Surgical, LLC
446 Arricola Ave.
St.Augustine,  FL  32080
Correspondent Contact V. JOHN KILEJIAN
Regulation Number884.4530
Classification Product Code
HFX  
Date Received03/22/2001
Decision Date 05/03/2001
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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