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, Umbilical
510(k) Number K020718
Device Name SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
Applicant
Precision Dynamics Corp.
13880 Del Sur St.
San Fernando,  CA  91340 -3490
Applicant Contact KALYNA SNYLYK
Correspondent
Precision Dynamics Corp.
13880 Del Sur St.
San Fernando,  CA  91340 -3490
Correspondent Contact KALYNA SNYLYK
Regulation Number884.4530
Classification Product Code
HFW  
Date Received03/05/2002
Decision Date 06/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-