The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Stopcocks Advance Manifolds.
| Device ID | K897196 |
| 510k Number | K897196 |
| Device Name: | ADVANCE STOPCOCKS ADVANCE MANIFOLDS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-29 |
| Decision Date | 1990-03-27 |