Nylamid Mesh Pad Full & Half
FDA 510(k) K852011 · S. Jackson, Inc.
510(k) numberK852011
Submission
- Device name
- Nylamid Mesh Pad Full & Half
- Applicant
- S. Jackson, Inc.
Alexandria, VA, US - Received
- April 26, 1985
- Decision date
- June 11, 1985
- 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 Nylamid Mesh Pad Full & Half cleared by the FDA?
Nylamid Mesh Pad Full & Half (K852011) received a 510(k) decision of Substantially Equivalent on June 11, 1985, 46 days after the submission was received.
What is the product code of K852011?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.