Cleared Traditional

STEAM STERILIZER (AUTOCLAVE), DENTAL

K895638 · Porter Instrument Co., Inc. · General Hospital
Feb 1990
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K895638 is an FDA 510(k) clearance for the STEAM STERILIZER (AUTOCLAVE), DENTAL, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Porter Instrument Co., Inc. (Hatfield, US). The FDA issued a Cleared decision on February 22, 1990, 156 days after receiving the submission on September 19, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K895638 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1989
Decision Date February 22, 1990
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6880

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