FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10

Face Plate Hearing Aid

MAICO HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Faceplate, Custom In-the-ear Hearing Aid, Mca10.

Pre-market Notification Details

Device IDK862768
510k NumberK862768
Device Name:FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10
ClassificationFace Plate Hearing Aid
Applicant MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
ContactPaul M D'amico
CorrespondentPaul M D'amico
MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
Product CodeLRB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-22
Decision Date1986-08-13

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