The following data is part of a premarket notification filed by Medical Sterile Products, Inc. with the FDA for Msp Ophthalmic (eye Spud).
| Device ID | K931449 |
| 510k Number | K931449 |
| Device Name: | MSP OPHTHALMIC (EYE SPUD) |
| Classification | Spud, Ophthalmic |
| Applicant | MEDICAL STERILE PRODUCTS, INC. P.O. BOX 338 BO. ENSENADA ROAD 413, KM 0.2 Rincon, PR 00677 -0338 |
| Contact | David Wishinsky |
| Correspondent | David Wishinsky MEDICAL STERILE PRODUCTS, INC. P.O. BOX 338 BO. ENSENADA ROAD 413, KM 0.2 Rincon, PR 00677 -0338 |
| Product Code | HNA |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-23 |
| Decision Date | 1993-08-31 |