PAL (PROBE FOR ASPIRATION AND LAVAGE)

Laparoscope, General & Plastic Surgery

MARLO SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Pal (probe For Aspiration And Lavage).

Pre-market Notification Details

Device IDK911149
510k NumberK911149
Device Name:PAL (PROBE FOR ASPIRATION AND LAVAGE)
ClassificationLaparoscope, General & Plastic Surgery
Applicant MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby,  OH  44094
ContactScott C Marlow
CorrespondentScott C Marlow
MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby,  OH  44094
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-15
Decision Date1991-07-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.