The following data is part of a premarket notification filed by Repro-med Systems, Inc. with the FDA for Repro-med Neonate Aspiration System.
| Device ID | K892529 |
| 510k Number | K892529 |
| Device Name: | REPRO-MED NEONATE ASPIRATION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | REPRO-MED SYSTEMS, INC. P.O. BOX 191 713 NORTH STREET Middletown, NY 10940 |
| Contact | Andrew Sealfon |
| Correspondent | Andrew Sealfon REPRO-MED SYSTEMS, INC. P.O. BOX 191 713 NORTH STREET Middletown, NY 10940 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-06-12 |