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FDA 510(k)

ISOLATION GOWN

K-Number: K960999 · 1996-12-30

ApplicantCopioumed Intl., Inc.
Decision Date1996-12-30
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Copioumed Intl., Inc.. It received FDA 510(k) clearance on 1996-12-30 under 510(k) number K960999. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATION GOWN?

ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1996-12-30. The listed applicant is Copioumed Intl., Inc.. The 510(k) number is K960999.

When did ISOLATION GOWN receive FDA 510(k) clearance?

ISOLATION GOWN received FDA 510(k) clearance on 1996-12-30, under 510(k) number K960999.

Who is the listed applicant for ISOLATION GOWN?

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

What is the FDA product code for ISOLATION GOWN?

The FDA product code for ISOLATION GOWN is FYC.

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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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