510(k) K873771
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1987
- Date Received
- September 16, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Shunt System Implantation
- Device Class
- Class I
- Regulation Number
- 882.4545
- Review Panel
- NE
- Submission Type