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510(k) K020480

RBM by Smith & Nephew, Inc. — Product Code KGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2002
Date Received
February 13, 2002
Clearance Type
Special
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

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Other clearances for product code KGS

  • K030031 — SOFT TISSUE ANCHORING WASHERS (January 28, 2003)
  • 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)
  • K893995 — DERMACARE TIE HOLDER (August 11, 1989)