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FDA 510(k)

CURELLE, PREFERRED CURELLE, CUTEQ 2.5

K-Number: K020628 · 2002-05-24

ApplicantBioteque America, Inc.
Decision Date2002-05-24
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CURELLE, PREFERRED CURELLE, CUTEQ 2.5 is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque America, Inc.. It received FDA 510(k) clearance on 2002-05-24 under 510(k) number K020628. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURELLE, PREFERRED CURELLE, CUTEQ 2.5?

CURELLE, PREFERRED CURELLE, CUTEQ 2.5 is a medical device that received FDA 510(k) clearance on 2002-05-24. The listed applicant is Bioteque America, Inc.. The 510(k) number is K020628.

When did CURELLE, PREFERRED CURELLE, CUTEQ 2.5 receive FDA 510(k) clearance?

CURELLE, PREFERRED CURELLE, CUTEQ 2.5 received FDA 510(k) clearance on 2002-05-24, under 510(k) number K020628.

Who is the listed applicant for CURELLE, PREFERRED CURELLE, CUTEQ 2.5?

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

What is the FDA product code for CURELLE, PREFERRED CURELLE, CUTEQ 2.5?

The FDA product code for CURELLE, PREFERRED CURELLE, CUTEQ 2.5 is HHK.

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Related Devices (Code: HHK)

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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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