Cleared Traditional

SALINUM, ORCLAIR

K024148 · Sinclair Pharmaceuticals, Ltd. · Dental
Sep 2003
Decision
273d
Days
—
Risk

About This 510(k) Submission

K024148 is an FDA 510(k) clearance for the SALINUM, ORCLAIR, a Saliva, Artificial, submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on September 15, 2003, 273 days after receiving the submission on December 16, 2002. This device falls under the Dental review panel.

Submission Details

510(k) Number K024148 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2002
Decision Date September 15, 2003
Days to Decision 273 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD — Saliva, Artificial
Device Class —

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