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FDA 510(k)

Medline Non-Surgical Isolation Gown-

K-Number: K160471 · 2017-01-31

ApplicantMedline Industries, Inc.
Decision Date2017-01-31
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Non-Surgical Isolation Gown- is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2017-01-31 under approval number K160471. 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 Medline Non-Surgical Isolation Gown-?

Medline Non-Surgical Isolation Gown- is a medical device that received FDA 510(k) clearance on 2017-01-31. It is manufactured by Medline Industries, Inc.. The 510(k) number is K160471.

When was Medline Non-Surgical Isolation Gown- approved by the FDA?

Medline Non-Surgical Isolation Gown- received FDA 510(k) clearance on 2017-01-31, under approval number K160471.

What company makes Medline Non-Surgical Isolation Gown-?

Medline Non-Surgical Isolation Gown- is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Non-Surgical Isolation Gown-?

The FDA product code for Medline Non-Surgical 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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