PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Phonica Model 312-c Ite Hearing Instrument.

Pre-market Notification Details

Device IDK912570
510k NumberK912570
Device Name:PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactBill Lesiecki
CorrespondentBill Lesiecki
PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-11
Decision Date1991-06-26

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