BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC

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 Ppscl, Super-front Ppsc.

Pre-market Notification Details

Device IDK900829
510k NumberK900829
Device Name:BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville,  IL  60566
ContactD Huddleston
CorrespondentD 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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