The following data is part of a premarket notification filed by Iscience Surgical with the FDA for Iscience Surgical Fiberoptic Illuminator, Model Fi - 100.
| Device ID | K062259 |
| 510k Number | K062259 |
| Device Name: | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 |
| Classification | Endoilluminator |
| Applicant | ISCIENCE SURGICAL 4055 CAMPBELL AVENUE Menlo Park, CA 94025 |
| Contact | Grace Bartoo |
| Correspondent | Neil E Devine Jr INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2006-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893872001073 | K062259 | 000 |
| 00893872001608 | K062259 | 000 |