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COLTENE/WHALEDENT INC P781 ParaPost XP

Company Name

COLTENE/WHALEDENT INC

Catalog Number

P781

Description

ParaPost XP Casting Intro Kit

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Summary

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First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Additional Details

Device Identifier

D661P7811

Is RX

No

Is Over the Counter

No

Requires Sterilization

Yes

Is Sterile

No

Is Single Use

No

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	D661P7810
Package of 72	72	D661P7811