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 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K833135
Device Name INTRACATH INTRAVENOUS CATHETER UNIT
Applicant
Parke-Davis Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Parke-Davis Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/14/1983
Decision Date 11/21/1983
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
-
-