The following data is part of a premarket notification filed by Daum Corp. with the FDA for Daum Bone Biopsy Set.
| Device ID | K981320 |
| 510k Number | K981320 |
| Device Name: | DAUM BONE BIOPSY SET |
| Classification | Instrument, Biopsy |
| Applicant | DAUM CORP. 9645 WEHRLE DR. Clarence, NY 14031 |
| Contact | Gary J Sfeir, Rac |
| Correspondent | Gary J Sfeir, Rac DAUM CORP. 9645 WEHRLE DR. Clarence, NY 14031 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-10 |
| Decision Date | 1998-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838073494 | K981320 | 000 |
| 00884838073326 | K981320 | 000 |
| 00884838073319 | K981320 | 000 |
| 00884838073265 | K981320 | 000 |
| 00884838073258 | K981320 | 000 |
| 00884838073241 | K981320 | 000 |
| 00884838073234 | K981320 | 000 |
| 00884838073227 | K981320 | 000 |
| 00884838073210 | K981320 | 000 |
| 00884838073203 | K981320 | 000 |
| 00884838073197 | K981320 | 000 |
| 00884838073333 | K981320 | 000 |
| 00884838073340 | K981320 | 000 |
| 00884838073357 | K981320 | 000 |
| 00884838073487 | K981320 | 000 |
| 00884838073449 | K981320 | 000 |
| 00884838073432 | K981320 | 000 |
| 00884838073425 | K981320 | 000 |
| 00884838073418 | K981320 | 000 |
| 00884838073401 | K981320 | 000 |
| 00884838073395 | K981320 | 000 |
| 00884838073388 | K981320 | 000 |
| 00884838073371 | K981320 | 000 |
| 00884838073364 | K981320 | 000 |
| 00884838073180 | K981320 | 000 |