The following data is part of a premarket notification filed by Sterling Drug, Inc. with the FDA for Winthrop Pharmaceuticals Contrast Media Warmer.
| Device ID | K875275 |
| 510k Number | K875275 |
| Device Name: | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER |
| Classification | Bath, Incubators/water, All |
| Applicant | STERLING DRUG, INC. 90 PARK AVE. New York, NY 10016 |
| Contact | Carl E Calcagni |
| Correspondent | Carl E Calcagni STERLING DRUG, INC. 90 PARK AVE. New York, NY 10016 |
| Product Code | JTQ |
| CFR Regulation Number | 866.2540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-24 |
| Decision Date | 1988-01-27 |