The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Catheter Insertion Trays, Various #'s.
| Device ID | K831807 |
| 510k Number | K831807 |
| Device Name: | CATHETER INSERTION TRAYS, VARIOUS #'S |
| Classification | Catheter, Percutaneous |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-06 |
| Decision Date | 1983-07-18 |