The following data is part of a premarket notification filed by Pm Devices, Inc. with the FDA for Peripatch Sheet, Models 1.5p8, 1.5p16, 4p4, 4p6, 6p8 And 10p16.
| Device ID | K040835 |
| 510k Number | K040835 |
| Device Name: | PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 |
| 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 | 2004-03-31 |
| Decision Date | 2004-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663107414 | K040835 | 000 |
| 00840663109357 | K040835 | 000 |
| 00840663109340 | K040835 | 000 |
| 00840663109333 | K040835 | 000 |
| 00840663109227 | K040835 | 000 |
| 00840663109210 | K040835 | 000 |
| 00840663108831 | K040835 | 000 |
| 00840663108824 | K040835 | 000 |
| 00840663108800 | K040835 | 000 |
| 00840663108794 | K040835 | 000 |
| 00840663108787 | K040835 | 000 |
| 00840663108695 | K040835 | 000 |
| 00840663108701 | K040835 | 000 |
| 00840663106097 | K040835 | 000 |
| 00840663106806 | K040835 | 000 |
| 00840663106356 | K040835 | 000 |
| 00840663106349 | K040835 | 000 |
| 00840663106332 | K040835 | 000 |
| 00840663106325 | K040835 | 000 |
| 00840663106318 | K040835 | 000 |
| 00840663106301 | K040835 | 000 |
| 00840663106295 | K040835 | 000 |
| 00840663106288 | K040835 | 000 |
| 00840663106745 | K040835 | 000 |
| 00840663108718 | K040835 | 000 |