The following data is part of a premarket notification filed by Commercial Products & Engineering Co. with the FDA for Irrigator Stand.
| Device ID | K894891 |
| 510k Number | K894891 |
| Device Name: | IRRIGATOR STAND |
| Classification | Tenaculum, Uterine |
| Applicant | COMMERCIAL PRODUCTS & ENGINEERING CO. 5001 KENDRICK, S.E. Grand Rapids, MI 49512 |
| Contact | John Lamonaco |
| Correspondent | John Lamonaco COMMERCIAL PRODUCTS & ENGINEERING CO. 5001 KENDRICK, S.E. Grand Rapids, MI 49512 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1989-08-23 |