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 |