Cleared Traditional

COGAN CORP KITS OF DENTAL HAND INSTRUMENTS

K915299 · Cogan Corp. · Dental
Jan 1992
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K915299 is an FDA 510(k) clearance for the COGAN CORP KITS OF DENTAL HAND INSTRUMENTS, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Cogan Corp. (Portland, US). The FDA issued a Cleared decision on January 31, 1992, 73 days after receiving the submission on November 19, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number K915299 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1991
Decision Date January 31, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EGG — Attachment, Precision, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3165

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