Sterile Irrigation Trays

FDA 510(k) K890728 · Cypress Medical Products, Ltd.

Unknown

510(k) numberK890728

Submission

Device name
Sterile Irrigation Trays
Applicant
Cypress Medical Products, Ltd.
Mc Henry, IL, US
Received
February 13, 1989
Decision date
June 16, 1989
Decision
Unknown (SESD)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KYZ – Syringe, Irrigating (Non Dental)
Device class
Class I (low risk)
Regulation
21 CFR 880.6960
Specialty
General Hospital

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Questions and answers

When was Sterile Irrigation Trays cleared by the FDA?

Sterile Irrigation Trays (K890728) received a 510(k) decision of Unknown on June 16, 1989, 123 days after the submission was received.

What is the product code of K890728?

The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.