THE PHARAOH COMPENSATING FILTER

System, X-ray, Stationary

OCTOSTOP, INC.

The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for The Pharaoh Compensating Filter.

Pre-market Notification Details

Device IDK963941
510k NumberK963941
Device Name:THE PHARAOH COMPENSATING FILTER
ClassificationSystem, X-ray, Stationary
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 CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-01
Decision Date1996-11-27

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