The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Triguard(tm) Suction System.
| Device ID | K945950 |
| 510k Number | K945950 |
| Device Name: | TRIGUARD(TM) SUCTION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-06 |
| Decision Date | 1994-12-27 |