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FDA 510(k)

KILOWIN

K-Number: K971214 · 1998-06-11

ApplicantCadwell Laboratories, Inc.
Decision Date1998-06-11
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KILOWIN is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1998-06-11 under 510(k) number K971214. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KILOWIN?

KILOWIN is a medical device that received FDA 510(k) clearance on 1998-06-11. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K971214.

When did KILOWIN receive FDA 510(k) clearance?

KILOWIN received FDA 510(k) clearance on 1998-06-11, under 510(k) number K971214.

Who is the listed applicant for KILOWIN?

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

What is the FDA product code for KILOWIN?

The FDA product code for KILOWIN is GWE.

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Other records listing Cadwell Laboratories, Inc. as applicant

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Related Devices (Code: GWE)

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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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