K170762 is an FDA 510(k) clearance for the Cardinal Health Non-Reinforced Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 9, 2017, 88 days after receiving the submission on March 13, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K170762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2017 |
| Decision Date | June 09, 2017 |
| Days to Decision | 88 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 |