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 K941740
Device Name ACUFEX ROTATOR CUFF FIXATION BUTTON
Applicant
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact LYNNE ARONSON
Correspondent
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact LYNNE ARONSON
Regulation Number878.4930
Classification Product Code
KGS  
Date Received04/07/1994
Decision Date 06/30/1995
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
-
-