K011103 is an FDA 510(k) clearance for the BD SPRING BASED SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on June 13, 2001, 63 days after receiving the submission on April 11, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K011103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2001 |
| Decision Date | June 13, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |