The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Avi Infusion Pumps, Additional Intended Use.
Device ID | K933006 |
510k Number | K933006 |
Device Name: | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-21 |
Decision Date | 1993-10-25 |