STAR 42 PP-SP, STAR 42 PP-SL (T100)

Hearing Aid, Air Conduction

MAICO HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Star 42 Pp-sp, Star 42 Pp-sl (t100).

Pre-market Notification Details

Device IDK931041
510k NumberK931041
Device Name:STAR 42 PP-SP, STAR 42 PP-SL (T100)
ClassificationHearing Aid, Air Conduction
Applicant MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
ContactThomas A Dold
CorrespondentThomas A Dold
MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-01
Decision Date1993-06-01

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