Cleared Traditional

K884876 - S 4 INSTRUMENT STAND
(FDA 510(k) Clearance)

Dec 1988
Decision
24d
Days
Class 1
Risk

K884876 is an FDA 510(k) clearance for the S 4 INSTRUMENT STAND. This device is classified as a Tray, Surgical, Needle (Class I - General Controls, product code FSH).

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on December 15, 1988, 24 days after receiving the submission on November 21, 1988.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K884876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date December 15, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FSH — Tray, Surgical, Needle
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800

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