Cleared Traditional

K925367 - A-DEC 7284 CUSPIDOR, CASCADE (FDA 510(k) Clearance)

Apr 1994
Decision
537d
Days
Class 1
Risk

K925367 is an FDA 510(k) clearance for the A-DEC 7284 CUSPIDOR, CASCADE. This device is classified as a Unit, Suction Operatory (Class I - General Controls, product code EBR).

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on April 11, 1994, 537 days after receiving the submission on October 21, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K925367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date April 11, 1994
Days to Decision 537 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBR — Unit, Suction Operatory
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6640