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FDA 510(k)

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

K-Number: K160337 · 2017-07-07

ApplicantBam Corporation Limited
Decision Date2017-07-07
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is a medical device manufactured by Bam Corporation Limited. It received FDA 510(k) clearance on 2017-07-07 under approval number K160337. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Bam Corporation Limited. The 510(k) number is K160337.

When was Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns approved by the FDA?

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns received FDA 510(k) clearance on 2017-07-07, under approval number K160337.

What company makes Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is manufactured by Bam Corporation Limited.

What is the FDA product code for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

The FDA product code for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is QPC.

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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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