The following data is part of a premarket notification filed by Venture Technology, Inc. with the FDA for Fiber Optic Light Source I.
| Device ID | K812605 |
| 510k Number | K812605 |
| Device Name: | FIBER OPTIC LIGHT SOURCE I |
| Classification | Light, Fiber Optic, Dental |
| Applicant | VENTURE TECHNOLOGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EAY |
| CFR Regulation Number | 872.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1981-10-02 |