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 Dressing, Wound, Drug
510(k) Number K061060
Device Name TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
Applicant
Tissue Technologies Holdings, LLC
800 E. Leigh St.
Richmond,  VA  23219
Applicant Contact MARK LICATA
Correspondent
Tissue Technologies Holdings, LLC
800 E. Leigh St.
Richmond,  VA  23219
Correspondent Contact MARK LICATA
Classification Product Code
FRO  
Date Received04/17/2006
Decision Date 07/03/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-