Cleared Traditional

K800437 - SYRINGE TIP CONNECTOR
(FDA 510(k) Clearance)

Mar 1980
Decision
14d
Days
Class 1
Risk

K800437 is an FDA 510(k) clearance for the SYRINGE TIP CONNECTOR. This device is classified as a Dispenser, Liquid Medication (Class I - General Controls, product code KYX).

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980, 14 days after receiving the submission on February 27, 1980.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6430.

Submission Details

510(k) Number K800437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1980
Decision Date March 12, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code KYX — Dispenser, Liquid Medication
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6430

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