The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries, Inc. Defogger.
| Device ID | K982465 |
| 510k Number | K982465 |
| Device Name: | DEROYAL INDUSTRIES, INC. DEFOGGER |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Lois Marsh |
| Correspondent | Lois Marsh DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-08-11 |
| Summary: | summary |