The following data is part of a premarket notification filed by Hydrofera, Llc. with the FDA for Hydrofera Surgical Spear.
| Device ID | K974313 |
| 510k Number | K974313 |
| Device Name: | HYDROFERA SURGICAL SPEAR |
| Classification | Sponge, Ophthalmic |
| Applicant | HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Contact | Heather S Bond |
| Correspondent | Heather S Bond HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-03-02 |