PHONAK PICONET2 P2 AZ

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Piconet2 P2 Az.

Pre-market Notification Details

Device IDK961622
510k NumberK961622
Device Name:PHONAK PICONET2 P2 AZ
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville,  IL  60566
ContactFrancis K Kuk, Ph.d.,ccc-a
CorrespondentFrancis K Kuk, Ph.d.,ccc-a
PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville,  IL  60566
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-26
Decision Date1996-05-17
Summary:summary

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