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510(k) K792004

HEWSON LIGAMENT BUTTON by Richard'S Medical Equip., Inc. — Product Code KGS

K792004 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "HEWSON LIGAMENT BUTTON". The FDA issued a decision of Substantially Equivalent on November 5, 1979. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1979
Date Received
October 3, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retention Device, Suture
Device Class
Class I
Regulation Number
878.4930
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)
  • K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS (March 9, 1983)
  • K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP (March 9, 1983)
  • K823727 — SPECTRON PRIMARY STEM FEMORAL PROSTHES (March 8, 1983)
  • K823722 — SPECTRON LONG, STRAIGHT 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 KGS

  • K030031 — SOFT TISSUE ANCHORING WASHERS (January 28, 2003)
  • K020480 — RBM (March 12, 2002)
  • K964935 — SUTURE LOCK (February 25, 1997)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K930675 — MITEK CONE WASHER (November 9, 1993)
  • K904435 — VENTROFIL TENSION RELIEF SUTURE SET (August 29, 1991)
  • K911225 — TRAY DOUGH (April 17, 1991)
  • K904136 — SUTURE TENSION ADJUSTMENT REEL (October 2, 1990)
  • K902001 — SURGICAL RETENTION BAR (May 9, 1990)
  • K896310 — ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (November 20, 1989)

FDA data resources