The following data is part of a premarket notification filed by Iscience Surgical Corporation with the FDA for Iscience Surgical Ophthalmic Microcannula.
| Device ID | K041108 |
| 510k Number | K041108 |
| Device Name: | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA |
| Classification | Endoilluminator |
| Applicant | ISCIENCE SURGICAL CORPORATION 2 DELPHINUS Irvine, CA 92612 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon ISCIENCE SURGICAL CORPORATION 2 DELPHINUS Irvine, CA 92612 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-28 |
| Decision Date | 2004-06-22 |
| Summary: | summary |