The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Penlights.
| Device ID | K781228 |
| 510k Number | K781228 |
| Device Name: | PENLIGHTS |
| Classification | Light, Examination, Medical, Battery Powered |
| Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYT |
| CFR Regulation Number | 880.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-17 |
| Decision Date | 1978-09-07 |