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
510(k) Number K895674
Device Name MEDICOOL, CONTAINER FOR STORING INSULIN
Applicant
Medicool, Inc.
3001 Chapel Hill Rd.
Orange,  CA  92667
Applicant Contact WILLIE KRAWITZ
Correspondent
Medicool, Inc.
3001 Chapel Hill Rd.
Orange,  CA  92667
Correspondent Contact WILLIE KRAWITZ
Classification Product Code
LDQ
Date Received09/20/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-