Premium Plus Disposable Barrier Sleeve
K-Number: K163447 · 2017-06-20
ApplicantPremium Plus International Limited
Decision Date2017-06-20
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Premium Plus Disposable Barrier Sleeve is a medical device manufactured by Premium Plus International Limited. It received FDA 510(k) clearance on 2017-06-20 under approval number K163447. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Premium Plus Disposable Barrier Sleeve?
Premium Plus Disposable Barrier Sleeve is a medical device that received FDA 510(k) clearance on 2017-06-20. It is manufactured by Premium Plus International Limited. The 510(k) number is K163447.
When was Premium Plus Disposable Barrier Sleeve approved by the FDA?
Premium Plus Disposable Barrier Sleeve received FDA 510(k) clearance on 2017-06-20, under approval number K163447.
What company makes Premium Plus Disposable Barrier Sleeve?
Premium Plus Disposable Barrier Sleeve is manufactured by Premium Plus International Limited.
What is the FDA product code for Premium Plus Disposable Barrier Sleeve?
The FDA product code for Premium Plus Disposable Barrier Sleeve is PEM.
Other Devices by Premium Plus International Limited
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K191448Barrier SleevesIvoclar Vivadent, AG
K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.
K190949ScanX Barrier EnvelopesAir Techniques, Inc.
K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation
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.