PHONAK 9900 CIC

Hearing Aid, Air Conduction

PHONAK, INC.

The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak 9900 Cic.

Pre-market Notification Details

Device IDK953921
510k NumberK953921
Device Name:PHONAK 9900 CIC
ClassificationHearing Aid, Air Conduction
Applicant PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville,  IL  60566
ContactBill Lesiecki
CorrespondentBill Lesiecki
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 Received1995-08-21
Decision Date1995-09-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.