The following data is part of a premarket notification filed by Medical Hospital Equipment with the FDA for Mirage Intravenous Infusion Set Olovson-sterile.
| Device ID | K852616 |
| 510k Number | K852616 |
| Device Name: | MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDICAL HOSPITAL EQUIPMENT 236 THIRD AVENUE, SUITE A Chula Vista, CA 92010 |
| Contact | Vincent A Maruca |
| Correspondent | Vincent A Maruca MEDICAL HOSPITAL EQUIPMENT 236 THIRD AVENUE, SUITE A Chula Vista, CA 92010 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1986-04-07 |