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510(k) K810379

EARETTE HEARING AID SEARS #8054 by Oticon Corp. — Product Code FSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1981
Date Received
February 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Binder, Abdominal
Device Class
Class I
Regulation Number
880.5160
Review Panel
HO
Submission Type

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  • K964683 — DIGIFOCUS ITE (December 12, 1996)
  • K963788 — PRIMOFOCUS COMPACT (November 27, 1996)
  • K961059 — DIGIFOCUS COMPACT (May 7, 1996)
  • K960284 — OTICON /PRIMOFOCUS (PF) (March 7, 1996)
  • K954794 — OTICON (November 13, 1995)
  • K951002 — AMENDMENTS TO MULTIFOCUS (September 18, 1995)
  • K950381 — OTICON/LOGIC (February 27, 1995)

Other clearances for product code FSD

  • K892379 — THE POUCH GROIN & ABDOMINAL STRESS AID (July 20, 1989)
  • K822817 — DOCE ALL-IN-THE-EAR AID (January 18, 1983)
  • K770162 — MATERNITY SUPPORTER (February 9, 1977)
  • K760772 — DISPOSABLE ABDOMINAL BINDER (November 3, 1976)