Cleared Traditional

K920689 - DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM
(FDA 510(k) Clearance)

Nov 1993
Decision
637d
Days
Class 1
Risk

K920689 is an FDA 510(k) clearance for the DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM. This device is classified as a Microscope, Surgical, General & Plastic Surgery (Class I - General Controls, product code FSO).

Submitted by Deemed, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on November 12, 1993, 637 days after receiving the submission on February 14, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.

Submission Details

510(k) Number K920689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1992
Decision Date November 12, 1993
Days to Decision 637 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FSO — Microscope, Surgical, General & Plastic Surgery
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4700

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