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 Syringe, Piston
510(k) Number K984017
Device Name ALLISON MEDICAL INSULIN SYRINGE (AMIS)
Applicant
ALLISON MEDICAL, INC.
4301 SOUTH FEDERAL BLVD.,
SUITE 116
ENGLEWOOD,  CO  80110
Applicant Contact JUSTIN FERRIN
Correspondent
ALLISON MEDICAL, INC.
4301 SOUTH FEDERAL BLVD.,
SUITE 116
ENGLEWOOD,  CO  80110
Correspondent Contact JUSTIN FERRIN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/12/1998
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-