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 K910936
Device Name EMPTY I.V. CONTAINER
Applicant
Ellis Pharmaceutical Consulting, Inc.
913 State Rd.
Princeton,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
Ellis Pharmaceutical Consulting, Inc.
913 State Rd.
Princeton,  NJ  08540
Correspondent Contact LEVI ELLIS
Regulation Number880.5025
Classification Product Code
KPE  
Date Received03/06/1991
Decision Date 07/16/1991
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
-
-