The following data is part of a premarket notification filed by Deroyal Cardiovascular, Inc. with the FDA for Deroyal Disposable Rigid Light Handle And Adapter.
| Device ID | K993089 |
| 510k Number | K993089 |
| Device Name: | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER |
| Classification | Light, Surgical, Accessories |
| Applicant | DEROYAL CARDIOVASCULAR, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Lois Marsh |
| Correspondent | Lois Marsh DEROYAL CARDIOVASCULAR, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-10-14 |
| Summary: | summary |