510(k) K031008
K031008 is an FDA 510(k) premarket notification submitted by Aesculap for the device "AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)". The FDA issued a decision of Substantially Equivalent on May 9, 2003. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Aesculap has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2003
- Date Received
- March 31, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Neurosurgical Paddie
- Device Class
- Class II
- Regulation Number
- 882.4700
- Review Panel
- NE
- Submission Type