K100754 is an FDA 510(k) clearance for the GRAFT DELIVERY SYSTEM MODEL SA-6115. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 9, 2010, 84 days after receiving the submission on March 17, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K100754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2010 |
| Decision Date | June 09, 2010 |
| Days to Decision | 84 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 |