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 Band, Material, Orthodontic
510(k) Number K931980
Device Name STAINLESS STEEL ORTHODONTIC PRODUCTS
Applicant
Ortho Organizers, Inc.
1619 S. Rancho Santa Fe Rd.
San Marcos,  CA  92069
Applicant Contact CHUCK TYRRELL
Correspondent
Ortho Organizers, Inc.
1619 S. Rancho Santa Fe Rd.
San Marcos,  CA  92069
Correspondent Contact CHUCK TYRRELL
Regulation Number872.5410
Classification Product Code
DYO  
Subsequent Product Codes
DZC   ECN   EJF  
Date Received04/22/1993
Decision Date 09/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-