K875275 is an FDA 510(k) clearance for the WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER. This device is classified as a Bath, Incubators/water, All (Class I - General Controls, product code JTQ).
Submitted by Sterling Drug, Inc. (New York, US). The FDA issued a Cleared decision on January 27, 1988, 34 days after receiving the submission on December 24, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2540.
| 510(k) Number | K875275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1987 |
| Decision Date | January 27, 1988 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTQ — Bath, Incubators/water, All |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2540 |