RETURN PATH DIATHERMY HANDLE

Apparatus, Cautery, Radiofrequency, Ac-powered

MIRA, INC.

The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Return Path Diathermy Handle.

Pre-market Notification Details

Device IDK941495
510k NumberK941495
Device Name:RETURN PATH DIATHERMY HANDLE
ClassificationApparatus, Cautery, Radiofrequency, Ac-powered
Applicant MIRA, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
MIRA, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeHQR  
CFR Regulation Number886.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-28
Decision Date1994-07-15

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