Instrument Kits

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

ANTHOGYR

The following data is part of a premarket notification filed by Anthogyr with the FDA for Instrument Kits.

Pre-market Notification Details

Device IDK160730
510k NumberK160730
Device Name:Instrument Kits
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant ANTHOGYR 2237 Avenue Andre Lasquin Sallanches,  FR 74700
ContactTherese Candau
CorrespondentTherese Candau
ANTHOGYR 2237 Avenue Andre Lasquin Sallanches,  FR 74700
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-16
Decision Date2017-04-27
Summary:summary

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