SILENT PARTNER MODEL 10-2001

Generator, Oxygen, Portable

MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Silent Partner Model 10-2001.

Pre-market Notification Details

Device IDK861011
510k NumberK861011
Device Name:SILENT PARTNER MODEL 10-2001
ClassificationGenerator, Oxygen, Portable
Applicant MEDICAL DEVICES, INC. 5000 DUFFERIN STREET, UNIT N DOWNSVIEW Ontario M3h 5t5,  CA
ContactSteven Serber
CorrespondentSteven Serber
MEDICAL DEVICES, INC. 5000 DUFFERIN STREET, UNIT N DOWNSVIEW Ontario M3h 5t5,  CA
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-18
Decision Date1986-04-04

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