Cleared Traditional

MUCUS SPECIMEN TRAP

K962168 · Sage Products, Inc. · General Hospital
Jul 1996
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K962168 is an FDA 510(k) clearance for the MUCUS SPECIMEN TRAP, a Bottle, Collection, Vacuum (Class II — Special Controls, product code KDQ), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on July 22, 1996, 47 days after receiving the submission on June 5, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K962168 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1996
Decision Date July 22, 1996
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDQ — Bottle, Collection, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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