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 Mesh, Surgical, Polymeric
510(k) Number K093524
Device Name PIVIT A/B ST AND PIVIT A/B ST-R
Applicant
Tyrx, Inc.
1 Deer Park Dr. Suite G
Monmouth Junction,  NJ  08852
Applicant Contact MARK CITRON
Correspondent
Tyrx, Inc.
1 Deer Park Dr. Suite G
Monmouth Junction,  NJ  08852
Correspondent Contact MARK CITRON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/16/2009
Decision Date 03/26/2010
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
Predetermined Change
Control Plan Authorized		 No
-
-