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510(k) K961593

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS by Segi Hearing Aid Co. — Product Code LRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1996
Date Received
April 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Face Plate Hearing Aid
Device Class
Class I
Regulation Number
874.3300
Review Panel
EN
Submission Type

Other clearances for product code LRB

  • K974219 — FACEPLATE ASSEMBLY (February 20, 1998)
  • K942722 — MODULE PROGRAM (September 6, 1994)
  • K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (June 17, 1994)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (February 9, 1994)
  • K933044 — SILVER LD MODULE, ITE (August 2, 1993)
  • K933037 — GOLD K AMP, ITE (August 2, 1993)
  • K933046 — SILVER L MODULE, ITE (August 2, 1993)
  • K933043 — SILVER PPP MODULE, ITE (August 2, 1993)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)
  • K933039 — GOLD L MODULE, ITE (August 2, 1993)