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 Plate, Bone
510(k) Number K023486
Device Name OSSTAPLE, MAXILLOFACIAL
Applicant
Biomedical Enterprises, Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Applicant Contact W. CASEY FOX
Correspondent
Biomedical Enterprises, Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Correspondent Contact W. CASEY FOX
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
HRS  
Date Received10/17/2002
Decision Date 10/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-