The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Effectiv (tm) Cap.
| Device ID | K080579 |
| 510k Number | K080579 |
| Device Name: | EFFECTIV (TM) CAP |
| Classification | Cap, Device Disinfectant |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Product Code | QBP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-09-11 |
| Summary: | summary |