K982059 is an FDA 510(k) clearance for the ROTECNO 2000 SURGICAL GOWN. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Encompass Group, LLC (Mcdonough, US). The FDA issued a Cleared decision on November 30, 1998, 172 days after receiving the submission on June 11, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K982059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1998 |
| Decision Date | November 30, 1998 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |