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, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K913526
Device Name SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
Applicant
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MARIAN D HARDING
Correspondent
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MARIAN D HARDING
Regulation Number876.5820
Classification Product Code
FJK  
Date Received08/08/1991
Decision Date 11/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-