10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT

Laparoscope, General & Plastic Surgery

MAYAGUEZ MEDICAL CENTER

The following data is part of a premarket notification filed by Mayaguez Medical Center with the FDA for 10.0mm Suction/irrigation Probe & Tubing Kit.

Pre-market Notification Details

Device IDK932805
510k NumberK932805
Device Name:10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT
ClassificationLaparoscope, General & Plastic Surgery
Applicant MAYAGUEZ MEDICAL CENTER 18 CRESTWOOD DR. Trophy Club,  TX  76262
ContactJohn Mayall
CorrespondentJohn Mayall
MAYAGUEZ MEDICAL CENTER 18 CRESTWOOD DR. Trophy Club,  TX  76262
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-09
Decision Date1993-08-16

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