The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Premium Lightweight Headlight.
| Device ID | K952691 |
| 510k Number | K952691 |
| Device Name: | WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT |
| Classification | Detector, Blood Level |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Mary Kay Tesoro |
| Correspondent | Mary Kay Tesoro WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FJC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-07-31 |