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, Hypodermic, Single Lumen
510(k) Number K002213
Device Name BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
Applicant
Hunter Research Laboratories, Inc.
1541 S. Vine St.
Denver,  CO  80210
Applicant Contact BARBARA PEDIGO
Correspondent
Hunter Research Laboratories, Inc.
1541 S. Vine St.
Denver,  CO  80210
Correspondent Contact BARBARA PEDIGO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/21/2000
Decision Date 10/03/2000
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
-
-