SINCLAIR WOUND AND SKIN EMULSION

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

SINCLAIR PHARMACEUTICALS, LTD.

The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Sinclair Wound And Skin Emulsion.

Pre-market Notification Details

Device IDK024367
510k NumberK024367
Device Name:SINCLAIR WOUND AND SKIN EMULSION
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey,  GB Gu7 2ab
ContactMichael Killeen
CorrespondentMichael Killeen
SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey,  GB Gu7 2ab
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2002-12-31
Decision Date2003-07-28
Summary:summary

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