BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Bte Super-front Ppcl4, Super-front Ppc4.

Pre-market Notification Details

Device IDK900830
510k NumberK900830
Device Name:BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville,  IL  60566
ContactJoe D Huddleston
CorrespondentJoe D Huddleston
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 Received1990-02-21
Decision Date1990-05-23

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