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 Prosthesis, Toe, Constrained, Polymer
510(k) Number K780132
Device Name IMPLANT, HINGE TOE, FLEX.
Applicant
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3720
Classification Product Code
KWH  
Date Received01/24/1978
Decision Date 02/06/1978
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
-
-