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 Surgical Film
510(k) Number K202425
Device Name SurgiLattice scaffold
Applicant
Tepha, Inc.
99 Hayden Ave. Suite 360
Lexington,  MA  02421
Applicant Contact Kavetha Ram
Correspondent
Tepha, Inc.
99 Hayden Ave. Suite 360
Lexington,  MA  02421
Correspondent Contact Connie Garrison
Regulation Number878.3300
Classification Product Code
OOD  
Subsequent Product Code
FTL  
Date Received08/25/2020
Decision Date 08/19/2021
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
Predetermined Change
Control Plan Authorized		 No
-
-