Coated Novafil, Polybutester, Mesh
FDA 510(k) K896946 · American Cyanamid Co.
510(k) numberK896946
Submission
- Device name
- Coated Novafil, Polybutester, Mesh
- Applicant
- American Cyanamid Co.
Danbury, CT, US - Received
- December 13, 1989
- Decision date
- May 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Coated Novafil, Polybutester, Mesh cleared by the FDA?
Coated Novafil, Polybutester, Mesh (K896946) received a 510(k) decision of Substantially Equivalent on May 7, 1990, 145 days after the submission was received.
What is the product code of K896946?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.