BARLE TISSUE ADHESIVE

Tissue Adhesive For The Topical Approximation Of Skin

ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

The following data is part of a premarket notification filed by Advanced Medical Solutions (plymouth) Ltd with the FDA for Barle Tissue Adhesive.

Pre-market Notification Details

Device IDK123133
510k NumberK123133
Device Name:BARLE TISSUE ADHESIVE
ClassificationTissue Adhesive For The Topical Approximation Of Skin
Applicant ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANAGAGE SCIENCE PARK Plymouth,  GB Pl7 5bg
ContactMichael Browne
CorrespondentMichael Browne
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANAGAGE SCIENCE PARK Plymouth,  GB Pl7 5bg
Product CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-04
Decision Date2013-05-22
Summary:summary

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