Cleared Traditional

K860977 - MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
(FDA 510(k) Clearance)

K860977 · Britt Corp., Inc. · Neurology device
Oct 1986
Decision
216d
Days
Class 3
Risk

K860977 is an FDA 510(k) clearance for the MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION. This device is classified as a Laser, Neurosurgical, Argon (Class III - Premarket Approval, product code LLF).

Submitted by Britt Corp., Inc. (Smithtown, US). The FDA issued a Cleared decision on October 16, 1986, 216 days after receiving the submission on March 14, 1986.

This device falls under the Neurology FDA review panel.

Submission Details

510(k) Number K860977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1986
Decision Date October 16, 1986
Days to Decision 216 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code LLF — Laser, Neurosurgical, Argon
Device Class Class III - Premarket Approval