The following data is part of a premarket notification filed by Daum Corp. with the FDA for Daum Biopsygun.
| Device ID | K974576 |
| 510k Number | K974576 |
| Device Name: | DAUM BIOPSYGUN |
| Classification | Instrument, Biopsy |
| Applicant | DAUM CORP. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith DAUM CORP. 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 | 1997-12-08 |
| Decision Date | 1998-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838072510 | K974576 | 000 |
| 00884838072503 | K974576 | 000 |
| 00884838072497 | K974576 | 000 |
| 00884838072480 | K974576 | 000 |