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510(k) K891247

BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC by Siemens Hearing Instruments, Inc. — Product Code ESF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
March 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

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  • K952940 — PERSONAL PROGRAMMER 2000 (July 26, 1995)
  • K951828 — FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (June 30, 1995)
  • K952263 — PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT (June 5, 1995)

Other clearances for product code ESF

  • K813224 — CERAVITAL CERAMIC EAR CANAL WALL PROSTH (April 21, 1982)