510(k) K990504
K990504 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "MEMOTHERM COLORECTAL STENT". The FDA issued a decision of Substantially Equivalent on March 16, 2000. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2000
- Date Received
- February 17, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Colonic, Metallic, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type