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510(k) K862629

SURGICAL LASER ACCESSORIES (SLA) CASE by Simpson/Basye, Inc. — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1986
Date Received
July 10, 1986
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 Simpson/Basye, Inc.

  • K926179 — SEDLACEK HANDLE (March 25, 1994)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891347 — REID ENDOCERVICAL SPREADER (March 29, 1989)
  • K891349 — CAMPION CERVICAL HOOK (March 29, 1989)
  • K891350 — NEWPORT CERVICAL MANIPULATOR (March 29, 1989)
  • K891348 — CAMPION LASER FORCEPS (March 22, 1989)
  • K870276 — HEATED INSTRUMENT BATH (May 7, 1987)
  • K862717 — HAND MIRROR (ENDOSCOPE) (July 30, 1986)
  • K790923 — MI-MARK ENDOCERVICAL SAMPLING SET (June 22, 1979)

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)