510(k) K911921
K911921 is an FDA 510(k) premarket notification submitted by Liaoning-Usa Corp. for the device "DISPOSABLE ISOLATION GOWN". The FDA issued a decision of Substantially Equivalent on May 13, 1991. The device falls under product code FYB (Gown, Patient), a Class II device regulated under 21 CFR 878.4040. Liaoning-Usa Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1991
- Date Received
- April 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Patient
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type