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, absorbable, abdominal hernia
510(k) Number K190185
Device Name Phasix ST Mesh with Open Positioning System
Applicant
C.R. Bard, Inc.
100 Crossings Boulevard
Warwick,  RI  02886
Applicant Contact Shirin Mate
Correspondent
C.R. Bard, Inc.
100 Crossings Boulevard
Warwick,  RI  02886
Correspondent Contact Shirin Mate
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
FTL   MDM   OOD  
Date Received02/01/2019
Decision Date 06/12/2019
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
-
-