• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name mesh, surgical
510(k) Number K081538
Device Name TUTOPATCH, TUTOMESH
Applicant
RTI BIOLOGICS, INC.
11621 research circle
p.o. box 2650
alachua,  FL  32616 -1627
Applicant Contact travis arola
Correspondent
RTI BIOLOGICS, INC.
11621 research circle
p.o. box 2650
alachua,  FL  32616 -1627
Correspodent Contact travis arola
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
DXZ   OXH   PAJ  
Date Received06/02/2008
Decision Date 06/19/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-