K872953 is an FDA 510(k) clearance for the DISPOSABLE I.V. ADMINISTRATION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Mac Lee Medical Products (Topeka, US). The FDA issued a Cleared decision on January 6, 1988, 161 days after receiving the submission on July 29, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K872953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1987 |
| Decision Date | January 06, 1988 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |