The following data is part of a premarket notification filed by Norton Texas Medical Products with the FDA for Custom Kwik Set And/or Pak.
| Device ID | K832517 |
| 510k Number | K832517 |
| Device Name: | CUSTOM KWIK SET AND/OR PAK |
| Classification | Catheter And Tip, Suction |
| Applicant | NORTON TEXAS MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-28 |
| Decision Date | 1983-10-14 |