Cleared Traditional

K771454 - MICRO SYRINGE & NEEDLE
(FDA 510(k) Clearance)

Aug 1977
Decision
12d
Days
Risk

K771454 is an FDA 510(k) clearance for the MICRO SYRINGE & NEEDLE..

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1977, 12 days after receiving the submission on August 4, 1977.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number K771454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date August 16, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code
Device Class