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510(k) K813093

RICHARDS ACETABULAR BRUSH by Richard'S Medical Equip., Inc. — Product Code HTR

K813093 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "RICHARDS ACETABULAR BRUSH". The FDA issued a decision of Substantially Equivalent on November 20, 1981. The device falls under product code HTR (Rasp), a Class I device regulated under 21 CFR 878.4800. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1981
Date Received
November 2, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Richard'S Medical Equip., Inc.

  • K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC (June 16, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS (March 9, 1983)
  • K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP (March 9, 1983)
  • K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS (March 9, 1983)
  • K823722 — SPECTRON LONG, STRAIGHT FEMORAL PROSTHES (March 8, 1983)
  • K823727 — SPECTRON PRIMARY STEM FEMORAL PROSTHES (March 8, 1983)
  • K830153 — RICHARDS INTRA-ARTICULAR SHAVER BLADES (February 28, 1983)
  • K830154 — COLLES FRACTURE FRAME (February 2, 1983)
  • K823725 — SPECTRON PROTRUSIO CUP (January 21, 1983)

Other clearances for product code HTR

  • K870333 — BIODYNAMICS SMALL JOINT BRUSH #1203 (February 13, 1987)
  • K870329 — ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (February 13, 1987)
  • K870349 — BIODYNAMICS FEMORAL CANAL BRUSH #1201 (February 13, 1987)
  • K812506 — THE ARTHROFILE (September 24, 1981)
  • K780771 — MICRO RASPS (May 16, 1978)
  • K771016 — INTERMEDULLARY BRUSH (January 12, 1978)
  • K771745 — RASPS FOR SCRAPING BONE (September 28, 1977)
  • K760109 — PROSTHESIS, TOTAL HIP-RASP (July 20, 1976)

FDA data resources