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 K143058
Device Name PuraDerm Gel
Applicant
3-D Matrix, Inc.
200 West St. Ste 14
Waltham,  MA  02451
Applicant Contact Lisa Spirio
Correspondent
TekTeam, LLC
2225 E. Bayshore Rd.
Palo Alto,  CA  94303
Correspondent Contact Denise Gottfried
Classification Product Code
FRO  
Date Received10/24/2014
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-