SCION BALLOON ELEVATOR

Laparoscope, General & Plastic Surgery

SCION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Scion International, Inc. with the FDA for Scion Balloon Elevator.

Pre-market Notification Details

Device IDK973698
510k NumberK973698
Device Name:SCION BALLOON ELEVATOR
ClassificationLaparoscope, General & Plastic Surgery
Applicant SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami,  FL  33126
ContactStephen Chakoff
CorrespondentStephen Chakoff
SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami,  FL  33126
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-26
Decision Date1998-03-31

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