The following data is part of a premarket notification filed by Pm Devices, Inc. with the FDA for Peripatch Sheet, Models 1.5p8, 4p4, 4p6, 6p8, 10p16, 1.5p16.
| Device ID | K031948 |
| 510k Number | K031948 |
| Device Name: | PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| 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 | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-24 |
| Decision Date | 2003-09-16 |