KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION

Gown, Surgical

MOLNLYCKE HEALTH CARE, INC.

The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Klinidrape Surgical Gowns, Non-reinforced, Basic Protections And Standard Protection.

Pre-market Notification Details

Device IDK000901
510k NumberK000901
Device Name:KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
ClassificationGown, Surgical
Applicant MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone,  PA  19022
ContactMiguel A Negron
CorrespondentMiguel A Negron
MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone,  PA  19022
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-21
Decision Date2000-07-05

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