510(k) K153613
K153613 is an FDA 510(k) premarket notification submitted by Acera Surgical, Inc. for the device "Cerafix Dura Substitute". The FDA issued a decision of Substantially Equivalent on March 16, 2016. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Acera Surgical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2016
- Date Received
- December 17, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dura Substitute
- Device Class
- Class II
- Regulation Number
- 882.5910
- Review Panel
- NE
- Submission Type