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510(k) K123450

PHONAK TINNITUS BALANCE by Phonak, LLC — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2013
Date Received
November 9, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

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  • K961653 — PHONAK SONA P2 (May 29, 1996)
  • K961622 — PHONAK PICONET2 P2 AZ (May 17, 1996)
  • K953921 — PHONAK 9900 CIC (September 18, 1995)
  • K945439 — PHONAK PICONET 232X-AZ HEARING INSTRUMENT (August 23, 1995)
  • K950758 — DYNA 231X (March 21, 1995)

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