The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Osteo-site Bone Biopsy Needle, Osteo-site Bone Biopsy Needle Set.
| Device ID | K170008 |
| 510k Number | K170008 |
| Device Name: | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set |
| Classification | Instrument, Biopsy |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Erum B. Nasir |
| Correspondent | Erum B. Nasir COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212025617 | K170008 | 000 |
| 00815212026409 | K170008 | 000 |
| 00815212023026 | K170008 | 000 |
| 00815212024313 | K170008 | 000 |
| 00815212024566 | K170008 | 000 |
| 00815212024573 | K170008 | 000 |
| 00815212024580 | K170008 | 000 |
| 00815212024603 | K170008 | 000 |
| 00815212024610 | K170008 | 000 |
| 00815212025587 | K170008 | 000 |
| 00815212025594 | K170008 | 000 |
| 00815212025600 | K170008 | 000 |
| 00815212026638 | K170008 | 000 |