Submission Details
| 510(k) Number | K200818 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 2020 |
| Decision Date | July 17, 2020 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
3DMax MID Anatomical Mesh
Jul 2020
Decision
109d
Days
Class 2
Risk
About This 510(k) Submission
K200818 is an FDA 510(k) clearance for the 3DMax MID Anatomical Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on July 17, 2020, 109 days after receiving the submission on March 30, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
Device Classification
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
Manufacturer
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