K020926 is an FDA 510(k) clearance for the EXTENSION SET, MODELS 1911-512. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on July 12, 2002, 113 days after receiving the submission on March 21, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K020926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2002 |
| Decision Date | July 12, 2002 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |