The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Parke-davis Surgical Light.
| Device ID | K801353 |
| 510k Number | K801353 |
| Device Name: | PARKE-DAVIS SURGICAL LIGHT |
| Classification | Lamp, Surgical |
| Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-09 |
| Decision Date | 1980-06-30 |