510(k) K160339
K160339 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Cardinal Health Isolation Gown". The FDA issued a decision of Substantially Equivalent on July 28, 2016. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2016
- Date Received
- February 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Isolation, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type