NEEDLESAFE HANDGUARD

Set, Administration, Intravascular

ADRIAN ANESTHESIA SYSTEMS, INC.

The following data is part of a premarket notification filed by Adrian Anesthesia Systems, Inc. with the FDA for Needlesafe Handguard.

Pre-market Notification Details

Device IDK931813
510k NumberK931813
Device Name:NEEDLESAFE HANDGUARD
ClassificationSet, Administration, Intravascular
Applicant ADRIAN ANESTHESIA SYSTEMS, INC. 3325 S. ADRIAN HIGHWAY Adrian,  MI  49221
ContactMartin Kempen
CorrespondentMartin Kempen
ADRIAN ANESTHESIA SYSTEMS, INC. 3325 S. ADRIAN HIGHWAY Adrian,  MI  49221
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-08
Decision Date1993-07-22

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