The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Iv Start Kit.
Device ID | K914475 |
510k Number | K914475 |
Device Name: | IV START KIT |
Classification | I.v. Start Kit |
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 | LRS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-08 |
Decision Date | 1992-03-18 |