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 External Mandibular Fixator And/Or Distractor
510(k) Number K040083
Device Name SYNTHES EXTERNAL MIDFACE DISTRACTOR
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact LISA M BOYLE
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact LISA M BOYLE
Regulation Number872.4760
Classification Product Code
MQN  
Date Received01/15/2004
Decision Date 03/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-