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FDA 510(k)

AQUISEN

K-Number: K952583 · 1995-08-24

ApplicantAquintel, Inc.
Decision Date1995-08-24
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQUISEN is the device name listed in this FDA 510(k) record. The listed applicant is Aquintel, Inc.. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K952583. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUISEN?

AQUISEN is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Aquintel, Inc.. The 510(k) number is K952583.

When did AQUISEN receive FDA 510(k) clearance?

AQUISEN received FDA 510(k) clearance on 1995-08-24, under 510(k) number K952583.

Who is the listed applicant for AQUISEN?

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

What is the FDA product code for AQUISEN?

The FDA product code for AQUISEN is LJH.

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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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