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 Staple, Fixation, Bone
510(k) Number K002695
Device Name MEMODYN STAPLE
Applicant
Telos Medical Equipment
1109 Sturbridge Rd.
Fallston,,  MD  21047
Applicant Contact AL E AUSTIN
Correspondent
Telos Medical Equipment
1109 Sturbridge Rd.
Fallston,,  MD  21047
Correspondent Contact AL E AUSTIN
Regulation Number888.3030
Classification Product Code
JDR  
Date Received08/29/2000
Decision Date 06/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-