The following data is part of a premarket notification filed by Iscience Surgical Corporation with the FDA for Iscience Surgical Viscoinjector.
| Device ID | K050716 |
| 510k Number | K050716 |
| Device Name: | ISCIENCE SURGICAL VISCOINJECTOR |
| Classification | Pump, Infusion, Ophthalmic |
| 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 | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893872001059 | K050716 | 000 |
| 00893872001585 | K050716 | 000 |