FDA 510(k)

Precision Screw

K号: K160385 · 2016-07-27

决定日期2016-07-27

产品代码OLO

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决定实质等同

器械摘要

Precision Screw is the device name listed in this FDA 510(k) record. The listed applicant is Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160385. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Precision Screw?

Precision Screw is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Cryptych Pty, Ltd.. The 510(k) number is K160385.

When did Precision Screw receive FDA 510(k) clearance?

Precision Screw received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160385.

Who is the listed applicant for Precision Screw?

The FDA 510(k) record lists Cryptych Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Screw?

The FDA product code for Precision Screw is OLO.

列明Cryptych Pty, Ltd.为申报人的其他记录

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