The following data is part of a premarket notification filed by Pm Devices, Inc. with the FDA for Peripatch Endo-sleeve.
| Device ID | K063556 |
| 510k Number | K063556 |
| Device Name: | PERIPATCH ENDO-SLEEVE |
| Classification | Mesh, Surgical |
| Applicant | PM DEVICES, INC. 13700 MAYFIELD PL. UNIT 2135 Richmond, CA V6v 2e4 |
| Contact | Tim Verspagen |
| Correspondent | Tim Verspagen PM DEVICES, INC. 13700 MAYFIELD PL. UNIT 2135 Richmond, 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 | 2006-11-27 |
| Decision Date | 2007-03-20 |