510(k) K160471
K160471 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline Non-Surgical Isolation Gown-". The FDA issued a decision of Substantially Equivalent on Jan 31, 2017. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2017
- Date Received
- Feb 19, 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
- 510(k)