The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Welcon Light Handle.
| Device ID | K894397 |
| 510k Number | K894397 |
| Device Name: | WELCON LIGHT HANDLE |
| Classification | Light, Surgical, Accessories |
| Applicant | WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Contact | Richard P Welch |
| Correspondent | Richard P Welch WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-10 |