510(k) K110724
K110724 is an FDA 510(k) premarket notification submitted by Omnia Spa for the device "SURGICAL PROCEDURE PACKS". The FDA issued a decision of Substantially Equivalent on June 23, 2011. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Omnia Spa has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2011
- Date Received
- March 16, 2011
- 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