SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

Dressing, Wound And Burn, Occlusive

ADVANCED MEDICAL SOLUTIONS GROUP PLC

The following data is part of a premarket notification filed by Advanced Medical Solutions Group Plc with the FDA for Spyrogel Hydrogel Wound And Burn Dressing Sa.

Pre-market Notification Details

Device IDK991287
510k NumberK991287
Device Name:SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
ClassificationDressing, Wound And Burn, Occlusive
Applicant ADVANCED MEDICAL SOLUTIONS GROUP PLC ROAD THREE, WINFORD INDUSTRIAL ESTATE Winsford, Cheshire,  GB Cw7 3pd
ContactChristopher Oakes
CorrespondentChristopher Oakes
ADVANCED MEDICAL SOLUTIONS GROUP PLC ROAD THREE, WINFORD INDUSTRIAL ESTATE Winsford, Cheshire,  GB Cw7 3pd
Product CodeMGP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-14
Decision Date1999-06-29
Summary:summary

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