The following data is part of a premarket notification filed by Daum Gmbh with the FDA for Daum Mri/conventional Biopsy Kit.
| Device ID | K991366 |
| 510k Number | K991366 |
| Device Name: | DAUM MRI/CONVENTIONAL BIOPSY KIT |
| Classification | Instrument, Biopsy |
| Applicant | DAUM GMBH P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith DAUM GMBH P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-20 |
| Decision Date | 1999-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838073005 | K991366 | 000 |
| 00884838072565 | K991366 | 000 |
| 00884838072572 | K991366 | 000 |
| 00884838072589 | K991366 | 000 |
| 00884838072596 | K991366 | 000 |
| 00884838072602 | K991366 | 000 |
| 00884838072923 | K991366 | 000 |
| 00884838072930 | K991366 | 000 |
| 00884838072947 | K991366 | 000 |
| 00884838072954 | K991366 | 000 |
| 00884838072961 | K991366 | 000 |
| 00884838072978 | K991366 | 000 |
| 00884838072985 | K991366 | 000 |
| 00884838072992 | K991366 | 000 |
| 00884838072527 | K991366 | 000 |