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510(k) K872645

AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR by Richards Medical Co., Inc. — Product Code LRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1987
Date Received
July 6, 1987
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 by Richards Medical Co., Inc.

  • K896106 — ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS (June 25, 1990)
  • K900628 — MODULAR HIP SYSTEM (May 9, 1990)
  • K896580 — UNI-POLAR HEAD (February 15, 1990)
  • K895241 — INTRAMEDULLARY HIP SCREW (January 4, 1990)
  • K884824 — TRICON-M TOTAL KNEE SYSTEM (November 21, 1989)
  • K896204 — ZIRCONIA CERAMIC HEAD ADD'L SIZES (November 20, 1989)
  • K895242 — PAPPAS TRI-FLANGE VENTILATION TUBE (November 17, 1989)
  • K893377 — RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS (November 16, 1989)
  • K885069 — ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) (September 1, 1989)
  • K892366 — POROUS GENESIS STEMMED TIBIAL COMPONENT (July 19, 1989)

Other clearances for product code LRB

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  • K961593 — INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (November 7, 1996)
  • 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)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)
  • K933046 — SILVER L MODULE, ITE (August 2, 1993)
  • K933043 — SILVER PPP MODULE, ITE (August 2, 1993)