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 Filter, Infusion Line
510(k) Number K940980
Device Name CHARGED SUPOR(R) FILTER EXTENSION SET
Applicant
B. Braun of America, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact THOMAS R RONCA
Correspondent
B. Braun of America, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact THOMAS R RONCA
Regulation Number880.5440
Classification Product Code
FPB  
Date Received03/01/1994
Decision Date 07/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-