The following data is part of a premarket notification filed by Medcanica, Inc. with the FDA for Ultra-cbx.
| Device ID | K991486 |
| 510k Number | K991486 |
| Device Name: | ULTRA-CBX |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | MEDCANICA, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn MEDCANICA, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-28 |
| Decision Date | 1999-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067009579 | K991486 | 000 |
| 05415067009562 | K991486 | 000 |
| 05415067009555 | K991486 | 000 |
| 05415067009548 | K991486 | 000 |
| 05415067009531 | K991486 | 000 |
| 05415067009524 | K991486 | 000 |
| 05415067009517 | K991486 | 000 |