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, Elastic, Orthodontic
510(k) Number K943417
Device Name ORTHODONTIC ELASTOMERIC TUBE/THREAD
Applicant
Jon-Ko Products, Inc.
10250 Camino Santa Fe
San Diego,  CA  92121
Applicant Contact STEPHEN MARMELLA
Correspondent
Jon-Ko Products, Inc.
10250 Camino Santa Fe
San Diego,  CA  92121
Correspondent Contact STEPHEN MARMELLA
Regulation Number872.5410
Classification Product Code
ECI  
Date Received07/15/1994
Decision Date 05/23/1995
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
-
-