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 Splint, Traction
510(k) Number K770898
Device Name FRACTURE CAST BRACE KIT, PLASTIC
Applicant
CHASE MFG. CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CHASE MFG. CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.5890
Classification Product Code
HSP  
Date Received05/16/1977
Decision Date 07/21/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-