The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Biliary Stent Prosthesis.
| Device ID | K844384 |
| 510k Number | K844384 |
| Device Name: | BILIARY STENT PROSTHESIS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00684995500204 | K844384 | 000 |
| 00684995500082 | K844384 | 000 |
| 00684995500075 | K844384 | 000 |
| 00684995500068 | K844384 | 000 |
| 00684995500051 | K844384 | 000 |
| 00684995500044 | K844384 | 000 |
| 00684995500037 | K844384 | 000 |
| 00684995500020 | K844384 | 000 |
| 00684995500013 | K844384 | 000 |
| 00684995500099 | K844384 | 000 |
| 00684995500105 | K844384 | 000 |
| 00684995500112 | K844384 | 000 |
| 00684995500198 | K844384 | 000 |
| 00684995500181 | K844384 | 000 |
| 00684995500174 | K844384 | 000 |
| 00684995500167 | K844384 | 000 |
| 00684995500150 | K844384 | 000 |
| 00684995500143 | K844384 | 000 |
| 00684995500136 | K844384 | 000 |
| 00684995500129 | K844384 | 000 |
| 00684995500006 | K844384 | 000 |