The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Isecure Syringe Cartridge Holder.
| Device ID | K063180 |
| 510k Number | K063180 |
| Device Name: | ISECURE SYRINGE CARTRIDGE HOLDER |
| Classification | Adaptor, Holder, Syringe |
| Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 DEPT. 389 Lake Forest, IL 60045 |
| Contact | Diane Rennpferd |
| Correspondent | Diane Rennpferd HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 DEPT. 389 Lake Forest, IL 60045 |
| Product Code | IQG |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-19 |
| Decision Date | 2006-12-11 |
| Summary: | summary |