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 Restraint, Protective
510(k) Number K963462
Device Name COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
Applicant
Bird & Cronin, Inc.
1200 Trapp Rd.
Saint Paul,  MN  55121
Applicant Contact MICHAEL FRAZER
Correspondent
Bird & Cronin, Inc.
1200 Trapp Rd.
Saint Paul,  MN  55121
Correspondent Contact MICHAEL FRAZER
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 11/21/1996
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
-
-