Submission Details
| 510(k) Number | K160339 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 08, 2016 |
| Decision Date | July 28, 2016 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health Isolation Gown
Jul 2016
Decision
171d
Days
Class 2
Risk
About This 510(k) Submission
K160339 is an FDA 510(k) clearance for the Cardinal Health Isolation Gown, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 28, 2016, 171 days after receiving the submission on February 8, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FYC — Gown, Isolation, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
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