The following data is part of a premarket notification filed by Alcove Medical, Inc. with the FDA for Neo 2 Line Suction System.
| Device ID | K960488 |
| 510k Number | K960488 |
| Device Name: | NEO 2 LINE SUCTION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | ALCOVE MEDICAL, INC. 803 N. 300 WEST, #405 Salt Lake City, UT 84103 |
| Contact | Cary P Jenkins |
| Correspondent | Cary P Jenkins ALCOVE MEDICAL, INC. 803 N. 300 WEST, #405 Salt Lake City, UT 84103 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-01 |
| Decision Date | 1996-04-26 |