ALOCLAIR ORAL SPRAY

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 Aloclair Oral Spray.

Pre-market Notification Details

Device IDK042722
510k NumberK042722
Device Name:ALOCLAIR ORAL SPRAY
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 ProductNo
Date Received2004-10-01
Decision Date2005-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00358962303005 K042722 000

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