510(k) K193346
K193346 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "Codman Surgical Patties & Strips". The FDA issued a decision of Substantially Equivalent on November 20, 2020. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2020
- Date Received
- December 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Paddie
- Device Class
- Class II
- Regulation Number
- 882.4700
- Review Panel
- NE
- Submission Type