Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name clamp, circumcision
510(k) Number K010867
Device Name KILEJIAN CIRCUMCISOR
Applicant
IRIS SURGICAL, LLC
446 ARRICOLA AVE.
ST.AUGUSTINE,  FL  32080 -4566
Applicant Contact V. JOHN KILEJIAN
Correspondent
IRIS SURGICAL, LLC
446 ARRICOLA AVE.
ST.AUGUSTINE,  FL  32080 -4566
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
-
-