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, absorbable, synthetic, polyglycolic acid
510(k) Number K091087
Device Name MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Applicant
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Applicant Contact JENNIFER BRENNAN
Correspondent
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Correspondent Contact JENNIFER BRENNAN
Regulation Number878.4493
Classification Product Code
GAM  
Date Received04/15/2009
Decision Date 04/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-