SURGICAL CAP CALOT

Cap, Surgical

ROSEBURG SA

The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Surgical Cap Calot.

Pre-market Notification Details

Device IDK851558
510k NumberK851558
Device Name:SURGICAL CAP CALOT
ClassificationCap, Surgical
Applicant ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington,  DC  20007
ContactChambord
CorrespondentChambord
ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington,  DC  20007
Product CodeFYF  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-16
Decision Date1985-04-30

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