The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Memotherm Colorectal Stent.
| Device ID | K990504 |
| 510k Number | K990504 |
| Device Name: | MEMOTHERM COLORECTAL STENT |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
| Contact | Marion Gordon |
| Correspondent | Marion Gordon C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-17 |
| Decision Date | 2000-03-16 |
| Summary: | summary |