510(k) K200522
K200522 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "AERO CHROME* Breathable Performance Surgical Gowns". The FDA issued a decision of Substantially Equivalent on Mar 16, 2020. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. O&M Halyard, Inc. has 25 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 2020
- Date Received
- Mar 2, 2020
- Clearance Type
- Abbreviated
- 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
- 510(k)