INTRAUTERINE HEMOSTASIS BALLOON STENT

Instrument, Manual, Specialized Obstetric-gynecologic

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Intrauterine Hemostasis Balloon Stent.

Pre-market Notification Details

Device IDK863439
510k NumberK863439
Device Name:INTRAUTERINE HEMOSTASIS BALLOON STENT
ClassificationInstrument, Manual, Specialized Obstetric-gynecologic
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactByron Wickett
CorrespondentByron Wickett
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeKNA  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-05
Decision Date1987-06-02

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