K123588 is an FDA 510(k) clearance for the INTRADERMAL ADAPTER. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by West Pharmaceutical Services, Inc. (Lionville, US). The FDA issued a Cleared decision on February 19, 2013, 90 days after receiving the submission on November 21, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K123588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2012 |
| Decision Date | February 19, 2013 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |