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, vascular, reprocessed
510(k) Number K120204
Device Name REPROCESSED FEMORAL COMPRESSION DEVICE
Applicant
STERILMED, INC.
11140 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact JASON SKRAMSTED
Correspondent
STERILMED, INC.
11140 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact JASON SKRAMSTED
Regulation Number870.4450
Classification Product Code
NMF  
Subsequent Product Code
DXC  
Date Received01/23/2012
Decision Date 04/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-