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510(k) K963049

STERI-AID KIT by Steri-Aid, Inc. — Product Code FQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1996
Date Received
July 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Color Change
Device Class
Class I
Regulation Number
880.2900
Review Panel
HO
Submission Type

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  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (September 12, 1979)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)