Cleared Traditional

K760552 - THERMOMETER STAND AND DUST COVER (FDA 510(k) Clearance)

Nov 1976
Decision
74d
Days
Class 2
Risk

K760552 is an FDA 510(k) clearance for the THERMOMETER STAND AND DUST COVER. This device is classified as a Thermometer, Clinical Mercury (Class II - Special Controls, product code FLK).

Submitted by Landmark Plastics (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976, 74 days after receiving the submission on August 30, 1976.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number K760552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1976
Decision Date November 12, 1976
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FLK — Thermometer, Clinical Mercury
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.2920

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