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 Pump, Infusion, Insulin
510(k) Number K022317
Device Name DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
Applicant
Sooil Development Co., Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
Sooil Development Co., Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number880.5725
Classification Product Code
LZG  
Date Received07/17/2002
Decision Date 08/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-