The following data is part of a premarket notification filed by Beech Medical, Inc. with the FDA for Mini-vol Extension Set.
| Device ID | K831087 |
| 510k Number | K831087 |
| Device Name: | MINI-VOL EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BEECH MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688516464 | K831087 | 000 |
| 50351688516273 | K831087 | 000 |
| 50351688516280 | K831087 | 000 |
| 50351688516297 | K831087 | 000 |
| 50351688516310 | K831087 | 000 |
| 50351688516327 | K831087 | 000 |
| 50351688516334 | K831087 | 000 |
| 50351688516341 | K831087 | 000 |
| 50351688516358 | K831087 | 000 |
| 50351688516365 | K831087 | 000 |
| 50351688516266 | K831087 | 000 |