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FDA 510(k)

AMUKIN 50% - AIRSPRAY(R)

K-Number: K885037 · 1990-10-19

ApplicantBernard J. Cooney, P.A.
Decision Date1990-10-19
Product CodeFKO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMUKIN 50% - AIRSPRAY(R) is the device name listed in this FDA 510(k) record. The listed applicant is Bernard J. Cooney, P.A.. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K885037. The device is classified under product code FKO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMUKIN 50% - AIRSPRAY(R)?

AMUKIN 50% - AIRSPRAY(R) is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Bernard J. Cooney, P.A.. The 510(k) number is K885037.

When did AMUKIN 50% - AIRSPRAY(R) receive FDA 510(k) clearance?

AMUKIN 50% - AIRSPRAY(R) received FDA 510(k) clearance on 1990-10-19, under 510(k) number K885037.

Who is the listed applicant for AMUKIN 50% - AIRSPRAY(R)?

The FDA 510(k) record lists Bernard J. Cooney, P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMUKIN 50% - AIRSPRAY(R)?

The FDA product code for AMUKIN 50% - AIRSPRAY(R) is FKO.

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Related Devices (Code: FKO)

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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