BIG PHIL

Needle, Hypodermic, Single Lumen

BIOMEDICAL WASTE SYSTEMS, INC.

The following data is part of a premarket notification filed by Biomedical Waste Systems, Inc. with the FDA for Big Phil.

Pre-market Notification Details

Device IDK946027
510k NumberK946027
Device Name:BIG PHIL
ClassificationNeedle, Hypodermic, Single Lumen
Applicant BIOMEDICAL WASTE SYSTEMS, INC. 200 HIGH ST. Boston,  MA  02110
ContactMichael H King
CorrespondentMichael H King
BIOMEDICAL WASTE SYSTEMS, INC. 200 HIGH ST. Boston,  MA  02110
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-09
Decision Date1995-01-26

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