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 Clip, Implantable
510(k) Number K133202
Device Name HEM-O-LOK LIGATING CLIP
Applicant
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact ASHLEA RICCI
Correspondent
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact ASHLEA RICCI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received10/17/2013
Decision Date 12/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-