The following data is part of a premarket notification filed by Cell Constructs I, Llc with the FDA for Progenamatrix.
Device ID | K182010 |
510k Number | K182010 |
Device Name: | ProgenaMatrix |
Classification | Dressing, Wound, Collagen |
Applicant | Cell Constructs I, LLC 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
Contact | Elizabeth O'keeffe |
Correspondent | Elizabeth O'keefe Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
Product Code | KGN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-27 |
Decision Date | 2019-01-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850017159129 | K182010 | 000 |
00850017159105 | K182010 | 000 |
00850017159068 | K182010 | 000 |
00850017159044 | K182010 | 000 |
00850017159020 | K182010 | 000 |
00850017159013 | K182010 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PROGENAMATRIX 87361002 5571432 Live/Registered |
Cell Constructs I, LLC 2017-03-07 |