The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Luxtec Fiberoptic Cables.
| Device ID | K864387 |
| 510k Number | K864387 |
| Device Name: | LUXTEC FIBEROPTIC CABLES |
| Classification | Source, Carrier, Fiberoptic Light |
| 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 | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1987-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854040420 | K864387 | 000 |