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 Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
510(k) Number K002063
Device Name BIOTRACE, MODEL 1730
Applicant
Bryan Corp.
Four Plympton St.
Woburn,  MA  01801
Applicant Contact ROSE S LOGSDON
Correspondent
Bryan Corp.
Four Plympton St.
Woburn,  MA  01801
Correspondent Contact ROSE S LOGSDON
Regulation Number882.5300
Classification Product Code
MYU  
Date Received07/07/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-