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510(k) K920423

OLYMPIC SMART SCALE CARE CENTER by Olympic Medical Corp. — Product Code FEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
January 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Malecot
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Olympic Medical Corp.

  • K081094 — OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (June 20, 2008)
  • K031149 — OLYMPIC CFM 6000 (May 14, 2003)
  • K020335 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 (June 18, 2002)
  • K001056 — OLYMPIC WARM-UP (September 29, 2000)
  • K983229 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM (March 23, 1999)
  • K971601 — OLYMPIC BILI-BASSINET (September 24, 1997)
  • K972193 — OLYMPIX MINI-PASTEURMATIC (58210) (September 5, 1997)
  • K971117 — WARMETTE (August 22, 1997)
  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954434 — OLYMPIC INFANT THERMOMETER (December 20, 1995)

Other clearances for product code FEW

  • K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (November 18, 2014)
  • K070879 — BARD MALECOT AND PEZZER DRAINS (April 24, 2007)
  • K981258 — MANAN MALECOT BASKET DRAINAGE CATHETER (April 22, 1998)
  • K954147 — MANAN MALECOT BASKET DRAINAGE CATHETER (March 26, 1996)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)