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510(k) K993544

SPACE-OR RETRACTOR by Advanced Surgical Concepts (Asc) — Product Code FFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1999
Date Received
October 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Advanced Surgical Concepts (Asc)

  • K011183 — OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE (June 15, 2001)
  • K010711 — ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR (May 22, 2001)
  • K002013 — OMNIPORT (September 29, 2000)

Other clearances for product code FFO

  • K870897 — KODNER ANAL PERIONEAL RETRACTOR (June 4, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)
  • K852083 — THE KENDALL URINARY OUTPUT MONITOR (September 20, 1985)