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 K991296
Device Name TUTOPATCH
Applicant
TUTOGEN MEDICAL U.S., INC.
13709 PROGRESS BLVD.
BOX 19 SOUTH WING
ALACHUA,  FL  32615
Applicant Contact PJ PARDO
Correspondent
TUTOGEN MEDICAL U.S., INC.
13709 PROGRESS BLVD.
BOX 19 SOUTH WING
ALACHUA,  FL  32615
Correspondent Contact PJ PARDO
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
DXZ   OXH   PAJ  
Date Received04/15/1999
Decision Date 10/06/2000
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
-
-