Question 1

Who is the manufacturer of ECONOMY 400 CWS WITH PVC DRAINS?

Accepted Answer

C.R. Bard, Inc. filed the 510(k) submission for ECONOMY 400 CWS WITH PVC DRAINS (K851084).

Question 2

What is the FDA product code for ECONOMY 400 CWS WITH PVC DRAINS?

Accepted Answer

GCY. It is classified under 21 CFR 878.4680 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was ECONOMY 400 CWS WITH PVC DRAINS cleared by the FDA?

Accepted Answer

Jun 4, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for ECONOMY 400 CWS WITH PVC DRAINS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ECONOMY 400 CWS WITH PVC DRAINS?

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	K851084
Device Name	ECONOMY 400 CWS WITH PVC DRAINS
Applicant	C.R. Bard, Inc.
Product Code	GCY · General, Plastic Surgery
Decision Date	Jun 4, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4680
Device Class	Class 1

ECONOMY 400 CWS WITH PVC DRAINS

Device Facts

Regulatory Classification

Identification