VARIANT OF OCTOSTOP AND OCTOPAQUE

Cradle, Patient, Radiologic

OCTOSTOP, INC.

The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Variant Of Octostop And Octopaque.

Pre-market Notification Details

Device IDK930124
510k NumberK930124
Device Name:VARIANT OF OCTOSTOP AND OCTOPAQUE
ClassificationCradle, Patient, Radiologic
Applicant OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc.,  CA H4l 4z1
ContactJean A Vezina
CorrespondentJean A Vezina
OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc.,  CA H4l 4z1
Product CodeKXH  
CFR Regulation Number892.1830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-12
Decision Date1994-02-09

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