The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Primary Sets.
| Device ID | K142367 |
| 510k Number | K142367 |
| Device Name: | Hospira Primary Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | HOSPIRA, INC. 375 N. FIELD DRIVE Lake Forest, IL 60045 |
| Contact | Catherine Kang |
| Correspondent | Catherine Kang HOSPIRA, INC. 375 N. FIELD DRIVE Lake Forest, IL 60045 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20887787009303 | K142367 | 000 |
| 20887787009297 | K142367 | 000 |
| 20887787009280 | K142367 | 000 |
| 20887787009273 | K142367 | 000 |
| 20887709120208 | K142367 | 000 |
| 10887709120218 | K142367 | 000 |