SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

Implant, Orbital, Extra-ocular

MIRA, INC.

The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Solid Dilicone Implants, Sdilicone Sponge Implants.

Pre-market Notification Details

Device IDK950806
510k NumberK950806
Device Name:SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
ClassificationImplant, Orbital, Extra-ocular
Applicant MIRA, INC. 414 QUAKER HWY. Uxbridge,  MA  01569
ContactRosina Robinson
CorrespondentRosina Robinson
MIRA, INC. 414 QUAKER HWY. Uxbridge,  MA  01569
Product CodeHQX  
CFR Regulation Number886.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-22
Decision Date1996-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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