MODEL DT-BAL, BALANCE SAVER

Monitor, Pressure, Intrauterine

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Model Dt-bal, Balance Saver.

Pre-market Notification Details

Device IDK895323
510k NumberK895323
Device Name:MODEL DT-BAL, BALANCE SAVER
ClassificationMonitor, Pressure, Intrauterine
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert Leavitt
CorrespondentRobert Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeKXO  
CFR Regulation Number884.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-29
Decision Date1989-10-24

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