SUCTION SYSTEM

Cannula, Surgical, General & Plastic Surgery

AXIOM MEDICAL, INC.

The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Suction System.

Pre-market Notification Details

Device IDK861306
510k NumberK861306
Device Name:SUCTION SYSTEM
ClassificationCannula, Surgical, General & Plastic Surgery
Applicant AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount,  CA  90723
ContactRoger Wood
CorrespondentRoger Wood
AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount,  CA  90723
Product CodeGEA  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-08
Decision Date1986-06-09

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