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 container, i.v.
510(k) Number K945193
Device Name ALL-IN-ONE TWO CHAMBER CONTAINER
Applicant
BAXTER HEALTHCARE CORP.
ROAD 144 KM 20.6
JAYUYA,  PR  00664
Applicant Contact DENNIS OCWIEJA
Correspondent
BAXTER HEALTHCARE CORP.
ROAD 144 KM 20.6
JAYUYA,  PR  00664
Correspondent Contact DENNIS OCWIEJA
Regulation Number880.5025
Classification Product Code
KPE  
Date Received10/24/1994
Decision Date 05/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-