The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Hi - Lux Illuminator.
| Device ID | K951647 |
| 510k Number | K951647 |
| Device Name: | WELCH ALLYN HI - LUX ILLUMINATOR |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | WELCH ALLYN, INC. 4619 JORDAN RD. P.O. BOX 187 Skaneateles Falls, NY 13153 -0187 |
| Contact | Mary K Tesoro |
| Correspondent | Mary K Tesoro WELCH ALLYN, INC. 4619 JORDAN RD. P.O. BOX 187 Skaneateles Falls, NY 13153 -0187 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-05-17 |