Gynecare, A Div. of Ethicon, Inc. · Class II · Cleared Jan 8, 2002
| K-number | K013718 |
| Device name | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR |
| Applicant | Gynecare, A Div. of Ethicon, Inc. |
| Product code | OTO |
| Device class | Class II |
| Decision date | Jan 8, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov