The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Tracheostomy Care And Cleaning Kits.
Device ID | K890726 |
510k Number | K890726 |
Device Name: | TRACHEOSTOMY CARE AND CLEANING KITS |
Classification | General Surgery Tray |
Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Contact | Varun Soni |
Correspondent | Varun Soni CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-13 |
Decision Date | 1989-03-10 |