510(k) K880570
K880570 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "DENVER PLEURO-PERITONEAL SHUNT". The FDA issued a decision of Substantially Equivalent on Jun 20, 1988. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Codman & Shurtleff, Inc. has 152 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 1988
- Date Received
- Feb 10, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shunt, Peritoneal
- Device Class
- Class II
- Regulation Number
- 876.5955
- Review Panel
- GU
- Submission Type
- 510(k)