GELCLAIR CONCENTRATED ORAL GEL

Dressing, Wound, Drug

SINCLAIR PHARMACEUTICALS, LTD.

The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Gelclair Concentrated Oral Gel.

Pre-market Notification Details

Device IDK013056
510k NumberK013056
Device Name:GELCLAIR CONCENTRATED ORAL GEL
ClassificationDressing, Wound, Drug
Applicant SINCLAIR PHARMACEUTICALS, LTD. 1 ALDER BROOK Chinley, High Peak,  GB Sk23 6dn
ContactPriscilla Cox
CorrespondentPriscilla Cox
SINCLAIR PHARMACEUTICALS, LTD. 1 ALDER BROOK Chinley, High Peak,  GB Sk23 6dn
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-11
Decision Date2001-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00370564456156 K013056 000

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