Mouthkote Oral Moisturizer, Model 50930-098

FDA 510(k) K062653 · Parnell Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK062653

Submission

Device name
Mouthkote Oral Moisturizer, Model 50930-098
Applicant
Parnell Pharmaceuticals, Inc.
San Rafael, CA, US
Received
September 7, 2006
Decision date
October 27, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFD – Saliva, Artificial
Device class
Unclassified

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Questions and answers

When was Mouthkote Oral Moisturizer, Model 50930-098 cleared by the FDA?

Mouthkote Oral Moisturizer, Model 50930-098 (K062653) received a 510(k) decision of Substantially Equivalent on October 27, 2006, 50 days after the submission was received.

What is the product code of K062653?

The FDA product code is LFD – Saliva, Artificial, a Unclassified device.