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
510(k) Number K141084
Device Name Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
Applicant
ACELL, INC
6640 ELI WHITNEY DR
SUITE 200
COLUMBIA,  MD  21046
Applicant Contact Salman Elmi
Correspondent
ACELL, INC
6640 ELI WHITNEY DR
SUITE 200
COLUMBIA,  MD  21046
Correspondent Contact Salman Elmi
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXH  
Date Received04/28/2014
Decision Date 06/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-