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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K981755
Device Name LM ANCHOR
Applicant
Li Medical Technologies, Inc.
4 Armstrong Rd.
Shelton,  CT  06484
Applicant Contact RHODEMANN LI
Correspondent
Li Medical Technologies, Inc.
4 Armstrong Rd.
Shelton,  CT  06484
Correspondent Contact RHODEMANN LI
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Codes
GAT   HWC  
Date Received05/18/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-