The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rich-mar Carbon Electrodes.
Device ID | K950491 |
510k Number | K950491 |
Device Name: | RICH-MAR CARBON ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 -0879 |
Contact | David Richards |
Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 -0879 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-06 |
Decision Date | 1995-03-29 |