The following data is part of a premarket notification filed by Daum Gmbh with the FDA for Daum Double-shoot Bisopsy Gun.
| Device ID | K010037 |
| 510k Number | K010037 |
| Device Name: | DAUM DOUBLE-SHOOT BISOPSY GUN |
| Classification | Instrument, Biopsy |
| Applicant | DAUM GMBH P.O. BOX 4341 Crofton, MD 21114 |
| Contact | Christina Smith |
| Correspondent | Christina 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 | 2001-01-04 |
| Decision Date | 2001-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838073463 | K010037 | 000 |
| 00884838073456 | K010037 | 000 |
| 00884838072640 | K010037 | 000 |
| 00884838072633 | K010037 | 000 |
| 00884838072558 | K010037 | 000 |
| 00884838072541 | K010037 | 000 |
| 00884838072534 | K010037 | 000 |