The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for 24-hour Urine Collection Cooling Wrap.
| Device ID | K781557 |
| 510k Number | K781557 |
| Device Name: | 24-HOUR URINE COLLECTION COOLING WRAP |
| Classification | Container, Specimen, Sterile |
| Applicant | SAGE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMH |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-11 |
| Decision Date | 1978-10-17 |