SIMMONS SHELL

Shell, Scleral

MIRA, INC.

The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Simmons Shell.

Pre-market Notification Details

Device IDK855105
510k NumberK855105
Device Name:SIMMONS SHELL
ClassificationShell, Scleral
Applicant MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
ContactMark W Furlong
CorrespondentMark W Furlong
MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
Product CodeHQT  
CFR Regulation Number886.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-23
Decision Date1986-03-31

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