The following data is part of a premarket notification filed by Urological Inc. with the FDA for Cook Sidearm Core Tissue Biopsy Device.
| Device ID | K041544 |
| 510k Number | K041544 |
| Device Name: | COOK SIDEARM CORE TISSUE BIOPSY DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | UROLOGICAL INC. 1100 W. MORGAN STREET Spencer, IN 47460 |
| Contact | Cindy Rumple |
| Correspondent | Cindy Rumple UROLOGICAL INC. 1100 W. MORGAN STREET Spencer, IN 47460 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-09 |
| Decision Date | 2004-07-22 |
| Summary: | summary |