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 Headgear, Extraoral, Orthodontic
510(k) Number K982088
Device Name AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
Applicant
Ortho Kinetics Corp.
1611a S. Melrose Dr.
Suite 16
Vista,  CA  92083
Applicant Contact STEVEN O LUSE
Correspondent
Ortho Kinetics Corp.
1611a S. Melrose Dr.
Suite 16
Vista,  CA  92083
Correspondent Contact STEVEN O LUSE
Regulation Number872.5500
Classification Product Code
DZB  
Date Received06/15/1998
Decision Date 09/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-