The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Krupin Eye Valve W/scleral Buckle.
| Device ID | K885125 |
| 510k Number | K885125 |
| Device Name: | KRUPIN EYE VALVE W/SCLERAL BUCKLE |
| Classification | Implant, Eye Valve |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Lewis H Marten |
| Correspondent | Lewis H Marten HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-01-24 |