ProgenaMatrix
Dressing, Wound, Collagen
Cell Constructs I, LLC
The following data is part of a premarket notification filed by Cell Constructs I, Llc with the FDA for Progenamatrix.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017159129 | K182010 | 000 |
| 00850017159105 | K182010 | 000 |
| 00850017159068 | K182010 | 000 |
| 00850017159044 | K182010 | 000 |
| 00850017159020 | K182010 | 000 |
| 00850017159013 | K182010 | 000 |
Trademark Results [ProgenaMatrix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGENAMATRIX 87361002 5571432 Live/Registered |
Cell Constructs I, LLC 2017-03-07 |
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