|
Device | GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX) |
Generic Name | Biologic material, dental |
Regulation Number | 872.3930 |
Applicant | Lynch Biologics LLC 5526 Joseph Street Franklin, TN 37064 |
PMA Number | P040013 |
Supplement Number | S020 |
Date Received | 01/21/2015 |
Decision Date | 03/09/2015 |
Product Code |
NQA |
Advisory Committee |
Dental |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR FINAL PATIENT LABELING. |