Cleared Traditional

AUKULYTE

K953610 · Aukland Medical Plastics, Inc. · Radiology

Sep 1995

Decision

55d

Days

Class 1

Risk

About This 510(k) Submission

K953610 is an FDA 510(k) clearance for the AUKULYTE, a Shield, Protective, Personnel (Class I — General Controls, product code KPY), submitted by Aukland Medical Plastics, Inc. (Cary, US). The FDA issued a Cleared decision on September 26, 1995, 55 days after receiving the submission on August 2, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number	K953610 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1995
Decision Date	September 26, 1995
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement