The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for Electro-mesh.
| Device ID | K932299 |
| 510k Number | K932299 |
| Device Name: | ELECTRO-MESH |
| Classification | Electrode, Cutaneous |
| Applicant | PRIZM MEDICAL, INC. 3030 BUSINESS PARK DR. SUITE C Norcross, GA 30071 |
| Contact | James Johnson |
| Correspondent | James Johnson PRIZM MEDICAL, INC. 3030 BUSINESS PARK DR. SUITE C Norcross, GA 30071 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-11 |
| Decision Date | 1994-07-01 |