Cleared Traditional

K831230 - PULSE LAVAGE (FDA 510(k) Clearance)

May 1983
Decision
33d
Days
Risk

K831230 is an FDA 510(k) clearance for the PULSE LAVAGE..

Submitted by Micro-Aire Surgical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1983, 33 days after receiving the submission on April 15, 1983.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K831230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date May 18, 1983
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class