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FDA 510(k)

AMNIOLENS

K-Number: K032104 · 2003-12-12

ApplicantBio-Tissue, Inc.
Decision Date2003-12-12
Product CodeNQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMNIOLENS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tissue, Inc.. It received FDA 510(k) clearance on 2003-12-12 under 510(k) number K032104. The device is classified under product code NQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNIOLENS?

AMNIOLENS is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Bio-Tissue, Inc.. The 510(k) number is K032104.

When did AMNIOLENS receive FDA 510(k) clearance?

AMNIOLENS received FDA 510(k) clearance on 2003-12-12, under 510(k) number K032104.

Who is the listed applicant for AMNIOLENS?

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

What is the FDA product code for AMNIOLENS?

The FDA product code for AMNIOLENS is NQB.

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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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