The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Quick-care Biopsy Needle.
| Device ID | K973565 |
| 510k Number | K973565 |
| Device Name: | QUICK-CARE BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-11-03 |
| Summary: | summary |