ANESTHESIA FACE MASK

Mask, Gas, Anesthetic

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Anesthesia Face Mask.

Pre-market Notification Details

Device IDK953295
510k NumberK953295
Device Name:ANESTHESIA FACE MASK
ClassificationMask, Gas, Anesthetic
Applicant MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis,  MO  63134
ContactRobert A Virag
CorrespondentRobert A Virag
MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis,  MO  63134
Product CodeBSJ  
CFR Regulation Number868.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-14
Decision Date1995-08-11

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