The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Synergetics Synerlight Fiber Optic Lightsource.
| Device ID | K964005 |
| 510k Number | K964005 |
| Device Name: | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE |
| Classification | Endoilluminator |
| Applicant | SYNERGETICS, INC. 15 FOXHUNT DR. Chesterfield, MO 63017 |
| Contact | James Taylor |
| Correspondent | James Taylor SYNERGETICS, INC. 15 FOXHUNT DR. Chesterfield, MO 63017 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-07 |
| Decision Date | 1997-06-09 |
| Summary: | summary |