Cleared Traditional

SST SALIVA SUPPORTING TABLETS

K023046 · Sinclair Pharmaceuticals, Ltd. · Pathology

Dec 2002

Decision

81d

Days

Class 1

Risk

About This 510(k) Submission

K023046 is an FDA 510(k) clearance for the SST SALIVA SUPPORTING TABLETS, a Stains, Chemical Solution (Class I — General Controls, product code LED), submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on December 2, 2002, 81 days after receiving the submission on September 12, 2002. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K023046 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2002
Decision Date	December 02, 2002
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF