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 suture, nonabsorbable, synthetic, polyamide
510(k) Number K123034
Device Name VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
Applicant
UNILENE S.A.C.
33 Golden Eagle Lane
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
UNILENE S.A.C.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.5020
Classification Product Code
GAR  
Subsequent Product Codes
GAP   GAW  
Date Received09/28/2012
Decision Date 05/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-