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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 K954736
Device Name ACCESS (POWERCLAVE)
Applicant
Mdt Biologic Co.
1777 E. Henrietta Rd.
P.O. Box 23077
Rochester,  NY  14692
Applicant Contact CHARLES O HANCOCK
Correspondent
Mdt Biologic Co.
1777 E. Henrietta Rd.
P.O. Box 23077
Rochester,  NY  14692
Correspondent Contact CHARLES O HANCOCK
Regulation Number880.6880
Classification Product Code
FLE  
Date Received10/16/1995
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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