BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM

Laparoscope, Gynecologic (and Accessories)

MARLO SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Balloon Cannula 15mm X 35mm,15mm X 55mm, 10/12mm X 55mm,10/12mm X 35mm,5mm X 35mm,2mm X 35mm.

Pre-market Notification Details

Device IDK960810
510k NumberK960810
Device Name:BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby,  OH  44094
ContactArthur S Goddard
CorrespondentArthur S Goddard
MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby,  OH  44094
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-28
Decision Date1996-10-21
Summary:summary

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