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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K915054
Device Name STATIM CASSETT AUTOCLAVE, MODIFICATION
Applicant
Scican
260 Yorkland Blvd.
Toronto, Ontario,  CA M2J 1R7
Applicant Contact DUNCAN NEWMAN
Correspondent
Scican
260 Yorkland Blvd.
Toronto, Ontario,  CA M2J 1R7
Correspondent Contact DUNCAN NEWMAN
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/04/1991
Decision Date 08/04/1992
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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