The following data is part of a premarket notification filed by Fidia Advanced Biopolymers Srl with the FDA for Hyalomatrix Co.
| Device ID | K003855 |
| 510k Number | K003855 |
| Device Name: | HYALOMATRIX CO |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | FIDIA ADVANCED BIOPOLYMERS SRL VIA PONTE DELLA FABBRICA,3/A 35031 Abano Terme (pd), IT 35031 |
| Contact | Paolo Rampazzo |
| Correspondent | Paolo Rampazzo FIDIA ADVANCED BIOPOLYMERS SRL VIA PONTE DELLA FABBRICA,3/A 35031 Abano Terme (pd), IT 35031 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-07-03 |