• 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 K130943
Device Name AIGIS RX R PM/ AIGIS RX R ICD
Applicant
TYRX , INC.
1 DEER PARK DR.
SUITE G
MONMOUTH JUNCTION,  NJ  08852
Applicant Contact SUSAN OLINGER
Correspondent
TYRX , INC.
1 DEER PARK DR.
SUITE G
MONMOUTH JUNCTION,  NJ  08852
Correspondent Contact SUSAN OLINGER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/04/2013
Decision Date 05/20/2013
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 Yes
-
-