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510(k) K972193

OLYMPIX MINI-PASTEURMATIC (58210) by Olympic Medical Corp. — Product Code LDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
June 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Pasteurization, Hot Water
Device Class
Class II
Regulation Number
880.6991
Review Panel
HO
Submission Type

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  • K971117 — WARMETTE (August 22, 1997)
  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954434 — OLYMPIC INFANT THERMOMETER (December 20, 1995)
  • K954846 — OLYMPIC SMART SCALE (December 14, 1995)

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  • K884151 — MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (May 16, 1989)
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  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K810311 — STERI-VERS (April 17, 1981)