MODIFICATION OF CUTINOVA THIN DRESSING

Dressing, Wound, Drug

BEIERSDORF-JOBT, INC.

The following data is part of a premarket notification filed by Beiersdorf-jobt, Inc. with the FDA for Modification Of Cutinova Thin Dressing.

Pre-market Notification Details

Device IDK984593
510k NumberK984593
Device Name:MODIFICATION OF CUTINOVA THIN DRESSING
ClassificationDressing, Wound, Drug
Applicant BEIERSDORF-JOBT, INC. 5825 CARNEGIE BLVD. Charlotte,  NC  28209 -4633
ContactAngelo R Pereira
CorrespondentAngelo R Pereira
BEIERSDORF-JOBT, INC. 5825 CARNEGIE BLVD. Charlotte,  NC  28209 -4633
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-28
Decision Date1999-03-01
Summary:summary

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