Cleared Traditional

K833387 - ARGON LASER SURGICAL SYSTEM 770
(FDA 510(k) Clearance)

Apr 1984
Decision
202d
Days
Risk

K833387 is an FDA 510(k) clearance for the ARGON LASER SURGICAL SYSTEM 770..

Submitted by Cooper Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1984, 202 days after receiving the submission on September 29, 1983.

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

Submission Details

510(k) Number K833387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1983
Decision Date April 18, 1984
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class