The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Wmt Collagen Dermal Matrix, 4 Cm X 7 Cm, Model 89xm-4x07, Vmt Collagen Dermal Matrix, 6 Cm X 8 Cm, Model 89xm-6x08.
| Device ID | K073219 |
| 510k Number | K073219 |
| Device Name: | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 |
| Classification | Mesh, Surgical |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Mona Inman |
| Correspondent | Mona Inman AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-15 |
| Decision Date | 2008-04-10 |
| Summary: | summary |