The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Avi(tm) Model 232 Standard Iv Administration Set.
| Device ID | K924207 |
| 510k Number | K924207 |
| Device Name: | AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Von Busch |
| Correspondent | Von Busch 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-05-26 |