The following data is part of a premarket notification filed by Habalan Med & Beauty Co.,ltd with the FDA for Pobling Miity 2.
Device ID | K163550 |
510k Number | K163550 |
Device Name: | Pobling MIITY 2 |
Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
Applicant | HABALAN MED & BEAUTY CO.,LTD 907, 219, GASANDIGITAL 1-RO, GEUMCHEON-GU Seoul, KR 08501 |
Contact | Ray Jeon |
Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
Product Code | NFO |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-19 |
Decision Date | 2017-12-20 |