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FDA 510(k)

ARGI-SATIN OR OPTI0-STAR

K-Number: K965216 · 1997-02-27

ApplicantArgen Precious Metals, Inc.
Decision Date1997-02-27
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARGI-SATIN OR OPTI0-STAR is the device name listed in this FDA 510(k) record. The listed applicant is Argen Precious Metals, Inc.. It received FDA 510(k) clearance on 1997-02-27 under 510(k) number K965216. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGI-SATIN OR OPTI0-STAR?

ARGI-SATIN OR OPTI0-STAR is a medical device that received FDA 510(k) clearance on 1997-02-27. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K965216.

When did ARGI-SATIN OR OPTI0-STAR receive FDA 510(k) clearance?

ARGI-SATIN OR OPTI0-STAR received FDA 510(k) clearance on 1997-02-27, under 510(k) number K965216.

Who is the listed applicant for ARGI-SATIN OR OPTI0-STAR?

The FDA 510(k) record lists Argen Precious Metals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGI-SATIN OR OPTI0-STAR?

The FDA product code for ARGI-SATIN OR OPTI0-STAR is ELL.

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Other records listing Argen Precious Metals, Inc. as applicant

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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.

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