510(k) K200824
K200824 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown". The FDA issued a decision of Substantially Equivalent on July 29, 2020. The device falls under product code FYA (Gown, 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 29, 2020
- Date Received
- March 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type