The following data is part of a premarket notification filed by Pm Devices, Inc. with the FDA for Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5c6, 5c8, 5c10.
| Device ID | K033985 |
| 510k Number | K033985 |
| Device Name: | PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 |
| Classification | Mesh, Surgical |
| Applicant | PM DEVICES, INC. 2135-13700 MAYFIELD PLACE Richmond, Bc, CA V6v 2e4 |
| Contact | Britta Dombovari |
| Correspondent | Britta Dombovari PM DEVICES, INC. 2135-13700 MAYFIELD PLACE Richmond, Bc, CA V6v 2e4 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-06-04 |
| Summary: | summary |