The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Stopcock/high Pressure Stopcock.
| Device ID | K915301 |
| 510k Number | K915301 |
| Device Name: | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK |
| 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 | 1991-11-21 |
| Decision Date | 1992-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333208665 | K915301 | 000 |
| 20886333206968 | K915301 | 000 |
| 20886333206975 | K915301 | 000 |
| 20886333206982 | K915301 | 000 |
| 20886333207002 | K915301 | 000 |
| 20886333207019 | K915301 | 000 |
| 20886333207026 | K915301 | 000 |
| 20886333207033 | K915301 | 000 |
| 20886333207040 | K915301 | 000 |
| 20886333207057 | K915301 | 000 |
| 20886333207064 | K915301 | 000 |
| 20886333207071 | K915301 | 000 |
| 20886333207088 | K915301 | 000 |
| 20886333207095 | K915301 | 000 |
| 20886333207125 | K915301 | 000 |
| 20886333207132 | K915301 | 000 |
| 20886333207156 | K915301 | 000 |
| 20886333207606 | K915301 | 000 |
| 10889942308125 | K915301 | 000 |