Cleared Traditional

K930094 - AUKUSLEEVE
(FDA 510(k) Clearance)

K930094 · Aukland Medical Plastics, Inc. · Dental device

Oct 1993

Decision

285d

Days

Class 1

Risk

K930094 is an FDA 510(k) clearance for the AUKUSLEEVE. This device is classified as a Handle, Instrument, Dental (Class I - General Controls, product code EJB).

Submitted by Aukland Medical Plastics, Inc. (Cary, US). The FDA issued a Cleared decision on October 20, 1993, 285 days after receiving the submission on January 8, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K930094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 08, 1993
Decision Date	October 20, 1993
Days to Decision	285 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement