The following data is part of a premarket notification filed by Cancer Technologies, Inc. with the FDA for Extravakit For Dimethylsulfoxide (dmso).
Device ID | K883242 |
510k Number | K883242 |
Device Name: | EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO) |
Classification | Syringe, Piston |
Applicant | CANCER TECHNOLOGIES, INC. C/O EXTRAVAKIT, INC. 209 S. TUCSON BLVD., BLDG B Tucson, AR 85716 |
Contact | Dorr, Ph.d |
Correspondent | Dorr, Ph.d CANCER TECHNOLOGIES, INC. C/O EXTRAVAKIT, INC. 209 S. TUCSON BLVD., BLDG B Tucson, AR 85716 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-02 |
Decision Date | 1988-10-12 |