The following data is part of a premarket notification filed by Hass Corp. with the FDA for Amber Mill Series And Amber Press Series.
Device ID | K160102 |
510k Number | K160102 |
Device Name: | Amber Mill Series And Amber Press Series |
Classification | Powder, Porcelain |
Applicant | HASS CORP. 77-14, GWAHAKDANJI-RO Gangneung-si, KR 210-340 |
Contact | Yongsu Kim |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-19 |
Decision Date | 2016-07-14 |
Summary: | summary |