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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Color Change
510(k) Number K963049
Device Name STERI-AID KIT
Applicant
STERI-AID, INC.
1057 STEELES AVE WEST,P.O. BOX
81614,CONCOURSE POSTAL OUTLET
NORTH YORK,ONTARIO,  CA M2R 3X1
Applicant Contact MARTIN ROMAIN
Correspondent
STERI-AID, INC.
1057 STEELES AVE WEST,P.O. BOX
81614,CONCOURSE POSTAL OUTLET
NORTH YORK,ONTARIO,  CA M2R 3X1
Correspondent Contact MARTIN ROMAIN
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received07/25/1996
Decision Date 11/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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