The following data is part of a premarket notification filed by Galenica Enterprises, Inc. with the FDA for Lighting Source System.
| Device ID | K923656 |
| 510k Number | K923656 |
| Device Name: | LIGHTING SOURCE SYSTEM |
| Classification | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Applicant | GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Contact | Betty Mailot |
| Correspondent | Betty Mailot GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Product Code | HIC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1994-09-08 |