The following data is part of a premarket notification filed by Neotech Products, Inc. with the FDA for Neotech Meconium Aspirator (sterile).
| Device ID | K880487 |
| 510k Number | K880487 |
| Device Name: | NEOTECH MECONIUM ASPIRATOR (STERILE) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
| Contact | Thomas R Thornbury |
| Correspondent | Thomas R Thornbury NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-05-06 |