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 Bag, Ice
510(k) Number K760951
Device Name DEVON COOL FACE
Applicant
Devon Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Devon Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6050
Classification Product Code
KYR  
Date Received11/01/1976
Decision Date 12/30/1976
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
-
-