EUTRA GEL FOR WOUND DRESSING

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

SWISS AMERICAN PRODUCTS, INC.

The following data is part of a premarket notification filed by Swiss American Products, Inc. with the FDA for Eutra Gel For Wound Dressing.

Pre-market Notification Details

Device IDK932291
510k NumberK932291
Device Name:EUTRA GEL FOR WOUND DRESSING
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant SWISS AMERICAN PRODUCTS, INC. 4315 ALPHA RD. Dallas,  TX  75244
ContactEugene Stubbs
CorrespondentEugene Stubbs
SWISS AMERICAN PRODUCTS, INC. 4315 ALPHA RD. Dallas,  TX  75244
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-10
Decision Date1994-07-18

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