The following data is part of a premarket notification filed by Paco Research Corp. with the FDA for Tracheobronchial Suction Kits W/catheters Eto.
| Device ID | K850864 |
| 510k Number | K850864 |
| Device Name: | TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | PACO RESEARCH CORP. ELLIS PHARMACEUTICAL CONSULTIN 913 STATE ROAD Princeton, NJ 08540 |
| Contact | Levi Ellis |
| Correspondent | Levi Ellis PACO RESEARCH CORP. ELLIS PHARMACEUTICAL CONSULTIN 913 STATE ROAD Princeton, NJ 08540 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-05-02 |