The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Fiber Optic Headlignt.
| Device ID | K952289 |
| 510k Number | K952289 |
| Device Name: | WELCH ALLYN FIBER OPTIC HEADLIGNT |
| Classification | Headlamp, Operating, Ac-powered |
| Applicant | WELCH ALLYN, INC. 4341 SOUTH STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Mary Kay Tesoro |
| Correspondent | Mary Kay Tesoro WELCH ALLYN, INC. 4341 SOUTH STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | HPQ |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-16 |
| Decision Date | 1995-07-14 |