Question 1

Who is the manufacturer of A-DEC DECADE 1015 CHAIR?

Accepted Answer

A-Dec, Inc. filed the 510(k) submission for A-DEC DECADE 1015 CHAIR (K903450).

Question 2

What is the FDA product code for A-DEC DECADE 1015 CHAIR?

Accepted Answer

KLC. It is classified under 21 CFR 872.6250 as a Class 1 device in the Dental panel.

Question 3

When was A-DEC DECADE 1015 CHAIR cleared by the FDA?

Accepted Answer

Oct 24, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for A-DEC DECADE 1015 CHAIR?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like A-DEC DECADE 1015 CHAIR?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K903450
Device Name	A-DEC DECADE 1015 CHAIR
Applicant	A-Dec, Inc.
Product Code	KLC · Dental
Decision Date	Oct 24, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6250
Device Class	Class 1

A-DEC DECADE 1015 CHAIR

Device Facts

Regulatory Classification

Identification