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510(k) K912104

MAJOR BASIN TRAY by Medical Device Inspection Co., Inc. — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 13, 1991
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 Medical Device Inspection Co., Inc.

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  • K931594 — THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM (December 21, 1993)
  • K933581 — POWERMATIC TREATMENT TABLE (November 5, 1993)
  • K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
  • K933580 — POWER WORK TABLE (November 5, 1993)
  • K933577 — POWERMATIC EXAMINATION TABLE (September 30, 1993)
  • K922045 — SHOWER CHAIRS (May 26, 1992)
  • K912075 — C-SECTION TRAY (April 7, 1992)
  • K914174 — STERILE DISPOSABLE WET SKIN SCRUB TRAY (February 24, 1992)

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)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)