ADDVANTAGE:TVC MARCON

Hearing Aid, Air Conduction

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Addvantage:tvc Marcon.

Pre-market Notification Details

Device IDK880284
510k NumberK880284
Device Name:ADDVANTAGE:TVC MARCON
ClassificationHearing Aid, Air Conduction
Applicant RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactRobert F Games
CorrespondentRobert F Games
RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-25
Decision Date1988-02-26

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