Caphosol Artificial Saliva

FDA 510(k) K991938 · Inpharma A.S.

Substantially Equivalent

510(k) numberK991938

Submission

Device name
Caphosol Artificial Saliva
Applicant
Inpharma A.S.
Northborough, MA, US
Received
June 9, 1999
Decision date
August 10, 1999
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 Caphosol Artificial Saliva cleared by the FDA?

Caphosol Artificial Saliva (K991938) received a 510(k) decision of Substantially Equivalent on August 10, 1999, 62 days after the submission was received.

What is the product code of K991938?

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