ADOBE C.I.C

Hearing Aid, Air Conduction

WIDEX HEARING AID CO., INC.

The following data is part of a premarket notification filed by Widex Hearing Aid Co., Inc. with the FDA for Adobe C.i.c.

Pre-market Notification Details

Device IDK943016
510k NumberK943016
Device Name:ADOBE C.I.C
ClassificationHearing Aid, Air Conduction
Applicant WIDEX HEARING AID CO., INC. 35-53 24TH ST. Long Island City,  NY  11106
ContactRon Meltsner
CorrespondentRon Meltsner
WIDEX HEARING AID CO., INC. 35-53 24TH ST. Long Island City,  NY  11106
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-24
Decision Date1994-12-14

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