The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Fluid Irrigation System.
| Device ID | K941388 |
| 510k Number | K941388 |
| Device Name: | 3M FLUID IRRIGATION SYSTEM |
| Classification | Arthroscope |
| Applicant | 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | Willard Larson |
| Correspondent | Willard Larson 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1994-10-07 |