BACT-HME (TM)

Condenser, Heat And Moisture (artificial Nose)

PHARMA SYSTEMS, INC.

The following data is part of a premarket notification filed by Pharma Systems, Inc. with the FDA for Bact-hme (tm).

Pre-market Notification Details

Device IDK903058
510k NumberK903058
Device Name:BACT-HME (TM)
ClassificationCondenser, Heat And Moisture (artificial Nose)
Applicant PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville,  NJ  07924
ContactHal Norris
CorrespondentHal Norris
PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville,  NJ  07924
Product CodeBYD  
CFR Regulation Number868.5375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-11
Decision Date1990-11-09

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