Irrigation Syringe Kit

FDA 510(k) K982435 · Sub-Q, Inc.

Substantially Equivalent

510(k) numberK982435

Submission

Device name
Irrigation Syringe Kit
Applicant
Sub-Q, Inc.
San Clemente, CA, US
Received
July 13, 1998
Decision date
November 6, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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 Irrigation Syringe Kit cleared by the FDA?

Irrigation Syringe Kit (K982435) received a 510(k) decision of Substantially Equivalent on November 6, 1998, 116 days after the submission was received.

What is the product code of K982435?

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