OXYGEN TUBINGS

Tubing, Pressure And Accessories

SEVEN HARVEST INTL. IMPORT & EXPORT

The following data is part of a premarket notification filed by Seven Harvest Intl. Import & Export with the FDA for Oxygen Tubings.

Pre-market Notification Details

Device IDK823142
510k NumberK823142
Device Name:OXYGEN TUBINGS
ClassificationTubing, Pressure And Accessories
Applicant SEVEN HARVEST INTL. IMPORT & EXPORT 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBYX  
CFR Regulation Number868.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-25
Decision Date1982-11-29

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