The following data is part of a premarket notification filed by Manan Manufacturing Co., Inc. with the FDA for Manan Contrast Media Administration Set.
| Device ID | K864405 |
| 510k Number | K864405 |
| Device Name: | MANAN CONTRAST MEDIA ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MANAN MANUFACTURING CO., INC. 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Contact | Manfred Mittermeier |
| Correspondent | Manfred Mittermeier MANAN MANUFACTURING CO., INC. 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-10 |
| Decision Date | 1986-12-18 |