The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-dehp.
| Device ID | K121032 |
| 510k Number | K121032 |
| Device Name: | PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP |
| Classification | Set, Administration, Intravascular |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Contact | Yuliya Matlin |
| Correspondent | Yuliya Matlin HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-06-21 |
| Summary: | summary |