510(k) K880401
K880401 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "DENVER PERITONEO-VENOUS SHUNT". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 1988
- Date Received
- January 29, 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