The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Sterile Irrigation Trays.
Device ID | K890728 |
510k Number | K890728 |
Device Name: | STERILE IRRIGATION TRAYS |
Classification | Syringe, Irrigating (non Dental) |
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 | KYZ |
CFR Regulation Number | 880.6960 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-13 |
Decision Date | 1989-06-16 |