The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Tracheostomy Care Kit.
Device ID | K792069 |
510k Number | K792069 |
Device Name: | TRACHEOSTOMY CARE KIT |
Classification | Tube, Tracheostomy (w/wo Connector) |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTO |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-15 |
Decision Date | 1979-10-30 |