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 needle, aspiration and injection, reusable
510(k) Number K903748
Device Name ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
Applicant
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Applicant Contact A. J NEWSON
Correspondent
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Correspondent Contact A. J NEWSON
Regulation Number878.4800
Classification Product Code
GDM  
Date Received08/16/1990
Decision Date 10/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-