FDA 510(k)

Amber Mill Series and Amber Press Series

K-Number: K160102 · 2016-07-14

Decision Date2016-07-14

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Amber Mill Series and Amber Press Series is a medical device manufactured by Hass Corp.. It received FDA 510(k) clearance on 2016-07-14 under approval number K160102. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amber Mill Series and Amber Press Series?

Amber Mill Series and Amber Press Series is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by Hass Corp.. The 510(k) number is K160102.

When was Amber Mill Series and Amber Press Series approved by the FDA?

Amber Mill Series and Amber Press Series received FDA 510(k) clearance on 2016-07-14, under approval number K160102.

What company makes Amber Mill Series and Amber Press Series?

Amber Mill Series and Amber Press Series is manufactured by Hass Corp..

What is the FDA product code for Amber Mill Series and Amber Press Series?

The FDA product code for Amber Mill Series and Amber Press Series is EIH.

Other Devices by Hass Corp.

K202952Amber Mill Q Series & Amber Mill Direct Series

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.