Cleared Traditional

K780759 - MODEL 902 STAND
(FDA 510(k) Clearance)

May 1978
Decision
11d
Days
Class 1
Risk

K780759 is an FDA 510(k) clearance for the MODEL 902 STAND. This device is classified as a Tray, Surgical, Needle (Class I - General Controls, product code FSH).

Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978, 11 days after receiving the submission on May 8, 1978.

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

Submission Details

510(k) Number K780759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1978
Decision Date May 19, 1978
Days to Decision 11 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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