K982098 is an FDA 510(k) clearance for the TUTODROP 1 AND TUTODROP 2. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on March 1, 1999, 259 days after receiving the submission on June 15, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K982098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1998 |
| Decision Date | March 01, 1999 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |