The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Mill-rose Rotatable Polypectomy Snare.
| Device ID | K951600 |
| 510k Number | K951600 |
| Device Name: | MILL-ROSE ROTATABLE POLYPECTOMY SNARE |
| Classification | Snare, Flexible |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Alan C Poje |
| Correspondent | Alan C Poje MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-12-18 |