The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Male-male Luer Lock Connector W/rota.
| Device ID | K840797 |
| 510k Number | K840797 |
| Device Name: | MALE-MALE LUER LOCK CONNECTOR W/ROTA |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-24 |