IUP - TIP TRANS, IUP - PROXI TRANS

Monitor, Pressure, Intrauterine

SCIENTIFIC DEVICE MANUFACTURER LLC.

The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Iup - Tip Trans, Iup - Proxi Trans.

Pre-market Notification Details

Device IDK961290
510k NumberK961290
Device Name:IUP - TIP TRANS, IUP - PROXI TRANS
ClassificationMonitor, Pressure, Intrauterine
Applicant SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael,  CA  94901
ContactRichard C Ball
CorrespondentRichard C Ball
SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael,  CA  94901
Product CodeKXO  
CFR Regulation Number884.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-04
Decision Date1996-10-15
Summary:summary

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