PENOX DUAL FLOW MINIFOLD

Yoke Assembly, Medical Gas

PENOX TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Penox Technologies, Inc. with the FDA for Penox Dual Flow Minifold.

Pre-market Notification Details

Device IDK851217
510k NumberK851217
Device Name:PENOX DUAL FLOW MINIFOLD
ClassificationYoke Assembly, Medical Gas
Applicant PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston,  PA  18640
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston,  PA  18640
Product CodeCAM  
CFR Regulation Number868.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-26
Decision Date1985-06-18

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