The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Carbon Electrode.
Device ID | K872044 |
510k Number | K872044 |
Device Name: | CARBON ELECTRODE |
Classification | Electrode, Cutaneous |
Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
Contact | Morad Davoudzadeh |
Correspondent | Morad Davoudzadeh FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-27 |
Decision Date | 1987-07-16 |