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 snare, surgical
510(k) Number K881224
Device Name ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
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 Number878.4800
Classification Product Code
GAE  
Date Received03/22/1988
Decision Date 06/01/1988
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
-
-