Fusion Classic - Oral Device For The Treatment Of Obstructive - SOMNOMED, INC.

Duns Number:623527962

Device Description: Oral Device For The Treatment Of Obstructive Sleep Apnea.

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More Product Details

Catalog Number

-

Brand Name

Fusion Classic

Version/Model Number

L7000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140278

Product Code Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

Public Device Record Key

6dfe509d-e4fb-4228-a1ec-f234dc03dce2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOMNOMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21
U Unclassified 1