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FDA 510(k)

SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS

K-Number: K991995 · 1999-08-27

ApplicantSoftchrome, Inc.
Decision Date1999-08-27
Product CodeMZD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Softchrome, Inc.. It received FDA 510(k) clearance on 1999-08-27 under 510(k) number K991995. The device is classified under product code MZD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS?

SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Softchrome, Inc.. The 510(k) number is K991995.

When did SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS receive FDA 510(k) clearance?

SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS received FDA 510(k) clearance on 1999-08-27, under 510(k) number K991995.

Who is the listed applicant for SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS?

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

What is the FDA product code for SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS?

The FDA product code for SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS is MZD.

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Official Source

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

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