ALOCLAIR ORAL RINSE

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 Rinse.

Pre-market Notification Details

Device IDK023155
510k NumberK023155
Device Name:ALOCLAIR ORAL RINSE
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey,  GB Gu7 2ab
ContactDenise Swift
CorrespondentDenise Swift
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 Received2002-09-23
Decision Date2002-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00358962302008 K023155 000

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