BTE PICO SCD, PICO SC

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Bte Pico Scd, Pico Sc.

Pre-market Notification Details

Device IDK900831
510k NumberK900831
Device Name:BTE PICO SCD, PICO SC
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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