Cleared Traditional

K771266 - STEAM STERILIZER (FDA 510(k) Clearance)

Aug 1977
Decision
20d
Days
Class 1
Risk

K771266 is an FDA 510(k) clearance for the STEAM STERILIZER. This device is classified as a Sterilizer, Boiling Water (Class I - General Controls, product code ECG).

Submitted by Amsco Hospital Products Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977, 20 days after receiving the submission on July 13, 1977.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6710.

Submission Details

510(k) Number K771266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1977
Decision Date August 02, 1977
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code ECG — Sterilizer, Boiling Water
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6710