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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 K910777
Device Name MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
Applicant
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692
Applicant Contact MARK N SMITH
Correspondent
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692
Correspondent Contact MARK N SMITH
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/22/1991
Decision Date 03/27/1992
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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