• 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
510(k) Number K183398
Device Name Endoform Restella
Applicant
Aroa Biosurgery Ltd.
2 Kingsford Smith Place
Airport Oaks,  NZ 2022
Applicant Contact Tina O’Brien
Correspondent
Aroa Biosurgery Ltd.
2 Kingsford Smith Place
Airport Oaks,  NZ 2022
Correspondent Contact Tina O’Brien
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
FTL  
Date Received12/07/2018
Decision Date 04/11/2019
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
-
-