The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Colonoscopic Injection Needle, C-323/c-325.
| Device ID | K921800 |
| 510k Number | K921800 |
| Device Name: | COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1993-02-08 |