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FDA 510(k)

UNNA-SLEEVE(TM)

K-Number: K903532 · 1990-11-02

ApplicantAci Medical, Inc.
Decision Date1990-11-02
Product CodeLLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNNA-SLEEVE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Aci Medical, Inc.. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K903532. The device is classified under product code LLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNNA-SLEEVE(TM)?

UNNA-SLEEVE(TM) is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Aci Medical, Inc.. The 510(k) number is K903532.

When did UNNA-SLEEVE(TM) receive FDA 510(k) clearance?

UNNA-SLEEVE(TM) received FDA 510(k) clearance on 1990-11-02, under 510(k) number K903532.

Who is the listed applicant for UNNA-SLEEVE(TM)?

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

What is the FDA product code for UNNA-SLEEVE(TM)?

The FDA product code for UNNA-SLEEVE(TM) is LLK.

Related Clinical Trials

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Other records listing Aci Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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