K982465 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. DEFOGGER, a Anti Fog Solution And Accessories, Endoscopy (Class II — Special Controls, product code OCT), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on August 11, 1998, 27 days after receiving the submission on July 15, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K982465 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 15, 1998 |
| Decision Date | August 11, 1998 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCT — Anti Fog Solution And Accessories, Endoscopy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens. |