The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Synergetics Synerlight Fiber Optic Lightsource.
| Device ID | K032598 |
| 510k Number | K032598 |
| Device Name: | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE |
| Classification | Endoilluminator |
| Applicant | SYNERGETICS, INC. 3845 CORPORATE CENTRE DR. St. Charles, MO 63304 |
| Contact | Dan Regan |
| Correspondent | Dan Regan SYNERGETICS, INC. 3845 CORPORATE CENTRE DR. St. Charles, MO 63304 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2003-11-24 |
| Summary: | summary |