Question 1

Who is the manufacturer of CANAL WALL PROSTHESIS?

Accepted Answer

Richards Medical Co., Inc. filed the 510(k) submission for CANAL WALL PROSTHESIS (K844960).

Question 2

What is the FDA product code for CANAL WALL PROSTHESIS?

Accepted Answer

FZD. It is classified under 21 CFR 878.3590 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was CANAL WALL PROSTHESIS cleared by the FDA?

Accepted Answer

Feb 26, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for CANAL WALL PROSTHESIS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CANAL WALL PROSTHESIS?

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	K844960
Device Name	CANAL WALL PROSTHESIS
Applicant	Richards Medical Co., Inc.
Product Code	FZD · General, Plastic Surgery
Decision Date	Feb 26, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3590
Device Class	Class 2

CANAL WALL PROSTHESIS

Device Facts

Regulatory Classification

Identification