The following data is part of a premarket notification filed by Fidia Advanced Biopolymers Srl with the FDA for Hyalomatrix Pa.
| Device ID | K073251 |
| 510k Number | K073251 |
| Device Name: | HYALOMATRIX PA |
| Classification | Dressing, Wound, Drug |
| Applicant | FIDIA ADVANCED BIOPOLYMERS SRL 1111 PENNSYLVANIA AVE NW Washington, DC 20004 |
| Contact | Sharon A Segal |
| Correspondent | Sharon A Segal FIDIA ADVANCED BIOPOLYMERS SRL 1111 PENNSYLVANIA AVE NW Washington, DC 20004 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2007-12-14 |
| Summary: | summary |