GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4

Hysteroscope (and Accessories)

GYRUS ACMI, INC.

The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4.

Pre-market Notification Details

Device IDK092278
510k NumberK092278
Device Name:GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
ClassificationHysteroscope (and Accessories)
Applicant GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
ContactGraham A.l. Baillie
CorrespondentGraham A.l. Baillie
GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-28
Decision Date2009-09-29
Summary:summary

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