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 K870395
Device Name CHURCHILL PARENTERAL NUTRITION BAG - EVA
Applicant
Churchill Corp.
One Summit Sq.
Rte. 413 & Doublewoods Rd.
Langhorne,  PA  19047
Applicant Contact DAVID W EVANS
Correspondent
Churchill Corp.
One Summit Sq.
Rte. 413 & Doublewoods Rd.
Langhorne,  PA  19047
Correspondent Contact DAVID W EVANS
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/30/1987
Decision Date 10/15/1987
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
-
-