The following data is part of a premarket notification filed by Hospira,inc. with the FDA for Lifeshield Vision Infusion Set With Pre-pierced Reseal.
| Device ID | K113683 |
| 510k Number | K113683 |
| Device Name: | LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL |
| Classification | Set, Administration, Intravascular |
| Applicant | HOSPIRA,INC. 375 N. FIELD DR. Lake Forest, IL 60045 |
| Contact | Karen Keener |
| Correspondent | Karen Keener HOSPIRA,INC. 375 N. 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 | 2011-12-15 |
| Decision Date | 2012-01-12 |
| Summary: | summary |