The following data is part of a premarket notification filed by Paco Research Corp. with the FDA for Tracheostomy Care Kit.
Device ID | K850446 |
510k Number | K850446 |
Device Name: | TRACHEOSTOMY CARE KIT |
Classification | Tube, Tracheostomy (w/wo Connector) |
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 | BTO |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-05 |
Decision Date | 1985-03-11 |