The following data is part of a premarket notification filed by Vital Concepts, Inc. with the FDA for Irrigation Sets.
| Device ID | K032832 |
| 510k Number | K032832 |
| Device Name: | IRRIGATION SETS |
| Classification | Arthroscope |
| Applicant | VITAL CONCEPTS, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2003-09-26 |