SPECIAL PROCEDURES PACK

Set, Administration, Intravascular

MARWOOD MEDICAL, INC.

The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for Special Procedures Pack.

Pre-market Notification Details

Device IDK850339
510k NumberK850339
Device Name:SPECIAL PROCEDURES PACK
ClassificationSet, Administration, Intravascular
Applicant MARWOOD MEDICAL, INC. BOX 8712 Greensboro,  NC  27410
ContactDenise Ranck
CorrespondentDenise Ranck
MARWOOD MEDICAL, INC. BOX 8712 Greensboro,  NC  27410
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-28
Decision Date1985-03-12

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