NORTEC CONNECTING TUBE SET

Tubing, Noninvasive

NORTH AMERICAN STERILIZATION & PACKAGING CO.

The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Nortec Connecting Tube Set.

Pre-market Notification Details

Device IDK911865
510k NumberK911865
Device Name:NORTEC CONNECTING TUBE SET
ClassificationTubing, Noninvasive
Applicant NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta,  NJ  07871
ContactHarry A Schlakman
CorrespondentHarry A Schlakman
NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta,  NJ  07871
Product CodeGAZ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-26
Decision Date1991-11-01

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