The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Am. Ph. Sterile Single-use Urethral Cath.
| Device ID | K820419 |
| 510k Number | K820419 |
| Device Name: | AM. PH. STERILE SINGLE-USE URETHRAL CATH |
| Classification | Catheter, Urological |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-16 |
| Decision Date | 1982-03-23 |