Catalog Number

10401

Brand Name

SICAT OPTISLEEP

Version/Model Number

10401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 13, 2022

Issuing Agency

In HIBCC

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

K153291

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

a733fc19-71e4-44d2-93a6-acca99ef8f53

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-