The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Subclavian Catheter Insertion Tray.
| Device ID | K802580 |
| 510k Number | K802580 |
| Device Name: | SUBCLAVIAN CATHETER INSERTION TRAY |
| Classification | Applicator, Absorbent Tipped, Non-sterile |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXF |
| CFR Regulation Number | 880.6025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-11-12 |