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FDA 510(k)

AMEDA HYGIENIKIT

K-Number: K011519 · 2001-08-15

ApplicantHollister, Inc.
Decision Date2001-08-15
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMEDA HYGIENIKIT is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 2001-08-15 under 510(k) number K011519. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDA HYGIENIKIT?

AMEDA HYGIENIKIT is a medical device that received FDA 510(k) clearance on 2001-08-15. The listed applicant is Hollister, Inc.. The 510(k) number is K011519.

When did AMEDA HYGIENIKIT receive FDA 510(k) clearance?

AMEDA HYGIENIKIT received FDA 510(k) clearance on 2001-08-15, under 510(k) number K011519.

Who is the listed applicant for AMEDA HYGIENIKIT?

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

What is the FDA product code for AMEDA HYGIENIKIT?

The FDA product code for AMEDA HYGIENIKIT is HGY.

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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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