The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Urinary Catheter Sampling Kit.
| Device ID | K800946 |
| 510k Number | K800946 |
| Device Name: | URINARY CATHETER SAMPLING KIT |
| Classification | Container, Specimen Mailer And Storage, Sterile |
| Applicant | SAGE PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDT |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-22 |
| Decision Date | 1980-06-20 |