The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Speculum, Vaginal, Metal Fiberoptic.
| Device ID | K864865 |
| 510k Number | K864865 |
| Device Name: | SPECULUM, VAGINAL, METAL FIBEROPTIC |
| Classification | Speculum, Vaginal, Metal, Fiberoptic |
| Applicant | LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge, MA 01566 |
| Contact | Thomas Wilk |
| Correspondent | Thomas Wilk LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge, MA 01566 |
| Product Code | HDG |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-01-09 |