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 set, administration, intravascular
510(k) Number K170595
Device Name IV Administration Sets
Applicant
B. Braun Medical Inc.
901 Macon Blvd
Allentown,  PA  18109
Applicant Contact Nancy Skocypec
Correspondent
B. Braun Medical Inc.
901 Macon Blvd
Allentown,  PA  18109
Correspondent Contact Nancy Skocypec
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/28/2017
Decision Date 11/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-