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, administration, intravascular
510(k) Number K924718
Device Name SHROUDED NEEDLE DEVICES
Applicant
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
Applicant Contact RALPH H JARBOE
Correspondent
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
Correspondent Contact RALPH H JARBOE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/21/1992
Decision Date 06/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-