510(k) K140369
K140369 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE NEURO SPONGE". The FDA issued a decision of Substantially Equivalent on September 26, 2014. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2014
- Date Received
- February 14, 2014
- 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