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 Retention Device, Suture
510(k) Number K884565
Device Name ACUFEX FIXATION BUTTON
Applicant
ACUFEX MICROSURGICAL, INC.
575 UNIVERSITY AVE.
NORWOOD,  MA  02062
Applicant Contact RICHARD E FRANKO
Correspondent
ACUFEX MICROSURGICAL, INC.
575 UNIVERSITY AVE.
NORWOOD,  MA  02062
Correspondent Contact RICHARD E FRANKO
Regulation Number878.4930
Classification Product Code
KGS  
Date Received11/01/1988
Decision Date 02/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-