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510(k) K905682

RICHARD-ALLAN CLAMP COVERS by Richard-Allan Medical — Product Code FSM

K905682 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical for the device "RICHARD-ALLAN CLAMP COVERS". The FDA issued a decision of Substantially Equivalent on February 19, 1991. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Richard-Allan Medical has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
December 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Richard-Allan Medical

  • K942207 — REFLEX INS INSUFFLATION NEEDLE (May 27, 1994)
  • K935105 — REFLEX ESP WITH FINGER SWITCHES (February 22, 1994)
  • K933508 — REFLEX SDD SURGICAL STAPLER (November 23, 1993)
  • K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) (November 19, 1993)
  • K924881 — REFLEX(R) ESP (July 23, 1993)
  • K924929 — REFLEX(R) ECA (July 21, 1993)
  • K905701 — RICHARD-ALLAN SHEET CLIP (February 19, 1991)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)

FDA data resources