The following data is part of a premarket notification filed by Trylon Associates, Ltd. with the FDA for Speculite Disposable Vaginal Light.
| Device ID | K853257 |
| 510k Number | K853257 |
| Device Name: | SPECULITE DISPOSABLE VAGINAL LIGHT |
| Classification | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Applicant | TRYLON ASSOCIATES, LTD. 26214 ATHENA AVE. Harbor City, CA 90710 |
| Contact | Martin L Lonly |
| Correspondent | Martin L Lonly TRYLON ASSOCIATES, LTD. 26214 ATHENA AVE. Harbor City, CA 90710 |
| Product Code | HIC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-02 |
| Decision Date | 1985-12-27 |