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FDA 510(k)

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

K-Number: K171162 · 2017-08-15

ApplicantPrestige Ameritech
Decision Date2017-08-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is a medical device manufactured by Prestige Ameritech. It received FDA 510(k) clearance on 2017-08-15 under approval number K171162. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield?

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is a medical device that received FDA 510(k) clearance on 2017-08-15. It is manufactured by Prestige Ameritech. The 510(k) number is K171162.

When was Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield approved by the FDA?

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield received FDA 510(k) clearance on 2017-08-15, under approval number K171162.

What company makes Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield?

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is manufactured by Prestige Ameritech.

What is the FDA product code for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield?

The FDA product code for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield is FXX.

Related Clinical Trials

NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING

Other Devices by Prestige Ameritech

K160100Prestige Ameritech Pediatric/Child’s Face mask K231741ProGear® Surgical Mask with Oxafence®, Model AV82030

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare

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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