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, extremity, inflatable, external
510(k) Number K874050
Device Name INFLATABLE FOOT & ANKLE SPLINT
Applicant
VINYL TECHNOLOGY, INC.
2110 EDWARDS AVE.
SO. EL MONTE,  CA  91733
Applicant Contact CARLOS A MOLLURA
Correspondent
VINYL TECHNOLOGY, INC.
2110 EDWARDS AVE.
SO. EL MONTE,  CA  91733
Correspondent Contact CARLOS A MOLLURA
Regulation Number878.3900
Classification Product Code
FZF  
Date Received10/05/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-