Question 1

Who is the manufacturer of COATED NOVAFIL, POLYBUTESTER, MESH?

Accepted Answer

American Cyanamid Co. filed the 510(k) submission for COATED NOVAFIL, POLYBUTESTER, MESH (K896946).

Question 2

What is the FDA product code for COATED NOVAFIL, POLYBUTESTER, MESH?

Accepted Answer

FTM. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was COATED NOVAFIL, POLYBUTESTER, MESH cleared by the FDA?

Accepted Answer

May 7, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for COATED NOVAFIL, POLYBUTESTER, MESH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like COATED NOVAFIL, POLYBUTESTER, MESH?

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	K896946
Device Name	COATED NOVAFIL, POLYBUTESTER, MESH
Applicant	American Cyanamid Co.
Product Code	FTM · General, Plastic Surgery
Decision Date	May 7, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2

COATED NOVAFIL, POLYBUTESTER, MESH

Device Facts

Regulatory Classification

Identification