The following data is part of a premarket notification filed by Hightech Development with the FDA for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant Elite.
| Device ID | K170835 |
| 510k Number | K170835 |
| Device Name: | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | Hightech Development Janovskeho 979/11 Prague, CZ 170 00 |
| Contact | Martin Boros |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2018-06-15 |