PHONAK SONA P2

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Sona P2.

Pre-market Notification Details

Device IDK961653
510k NumberK961653
Device Name:PHONAK SONA P2
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactFrancis Kuk, Ph.d.
CorrespondentFrancis Kuk, Ph.d.
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 Received1996-04-30
Decision Date1996-05-29
Summary:summary

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