510(k) K112796
K112796 is an FDA 510(k) premarket notification submitted by Cobes Industries Co., Ltd. for the device "SURGICAL GOWN (EO STERILIZED)". The FDA issued a decision of Substantially Equivalent on September 12, 2013. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Cobes Industries Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2013
- Date Received
- September 26, 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