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
510(k) Number K011208
Device Name BIOVER
Applicant
Biover AG
252 W. Ridley Ave.
Ridley Park,  PA  19078
Applicant Contact HEINZ E WICK
Correspondent
Biover AG
252 W. Ridley Ave.
Ridley Park,  PA  19078
Correspondent Contact HEINZ E WICK
Regulation Number870.4450
Classification Product Code
DXC  
Date Received04/19/2001
Decision Date 10/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-