FDA.report

510(k) K010867

Device
KILEJIAN CIRCUMCISOR
Applicant
Iris Surgical, LLC
510(k) number
K010867
Product code
HFX
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-03
Date received
2001-03-22
Regulation
884.4530
Classification name
Clamp, Circumcision
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
V. JOHN KILEJIAN
Address
446 Arricola Ave. St.Augustine FL US 32080 32080

FDA Registration Numbers

Source Documents

510(k) summary PDF

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