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 K892126
Device Name MITEK ANCHOR
Applicant
Mitek Surgical Products, Inc.
990 Washington St.
Dedham,  MA  02026
Applicant Contact EDWARD F KENT
Correspondent
Mitek Surgical Products, Inc.
990 Washington St.
Dedham,  MA  02026
Correspondent Contact EDWARD F KENT
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/30/1989
Decision Date 09/19/1989
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
-
-