The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Qualtex Light Handle And Light Handle Cover.
| Device ID | K911369 |
| 510k Number | K911369 |
| Device Name: | QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-05-13 |