The following data is part of a premarket notification filed by Pacific Device, Inc. with the FDA for Meconium Aspiration.
| Device ID | K912596 |
| 510k Number | K912596 |
| Device Name: | MECONIUM ASPIRATION |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
| Contact | Jim Caputo |
| Correspondent | Jim Caputo PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-10 |
| Decision Date | 1991-07-30 |