The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Nemdi.
Device ID | K843734 |
510k Number | K843734 |
Device Name: | NEMDI |
Classification | Epilator, High Frequency, Tweezer-type |
Applicant | NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590 |
Contact | Juergen F Kopf |
Correspondent | Juergen F Kopf NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590 |
Product Code | KCX |
CFR Regulation Number | 878.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-24 |
Decision Date | 1984-10-25 |