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, polyethylene
510(k) Number K151009
Device Name Nexus Suture
Applicant
BAYLIS MEDICAL COMPANY INC.
2645 MATHESON BLVD. EAST
MISSISSAUGA,  CA L4W 5S4
Applicant Contact Meghal Khakhar
Correspondent
BAYLIS MEDICAL COMPANY INC.
2645 MATHESON BLVD. EAST
MISSISSAUGA,  CA L4W 5S4
Correspondent Contact Meghal Khakhar
Regulation Number878.5000
Classification Product Code
GAT  
Date Received04/15/2015
Decision Date 08/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-