Catalog Number

-

Brand Name

Lutech

Version/Model Number

LT-300 SD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170446

Product Code

HEX

Product Code Name

Colposcope (And Colpomicroscope)

Public Device Record Key

63aed3ef-635c-4559-af4f-5d4837c2331c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-