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 Pack, Hot Or Cold, Disposable
510(k) Number K904819
Device Name SHUR-LOCK ICE WRAP SYSTEM
Applicant
Conco Medical Co.
380 Horace St.
Bridgeport,  CT  06610
Applicant Contact RUTH M NEMETH
Correspondent
Conco Medical Co.
380 Horace St.
Bridgeport,  CT  06610
Correspondent Contact RUTH M NEMETH
Regulation Number890.5710
Classification Product Code
IMD  
Date Received10/24/1990
Decision Date 12/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-