The following data is part of a premarket notification filed by Douglas Bueschel with the FDA for Kugel Hernia Patch.
| Device ID | K963141 |
| 510k Number | K963141 |
| Device Name: | KUGEL HERNIA PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DOUGLAS BUESCHEL 10 VIA ALICIA Santa Barbara, CA 93108 |
| Contact | Douglas Bueschel |
| Correspondent | Douglas Bueschel DOUGLAS BUESCHEL 10 VIA ALICIA Santa Barbara, CA 93108 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-13 |
| Decision Date | 1996-10-11 |
| Summary: | summary |