510(k) K891993
K891993 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "COLLAGEN NEUROSPONGE". The FDA issued a decision of Substantially Equivalent on March 23, 1990. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Vitaphore Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1990
- Date Received
- March 28, 1989
- 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