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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Chemical
510(k) Number K943654
Device Name HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
Applicant
Mdt Biologic Co.
19645 Rancho Way
Rancho Dominguez,  CA  90220
Applicant Contact MARK N SMITH, P.E.
Correspondent
Mdt Biologic Co.
19645 Rancho Way
Rancho Dominguez,  CA  90220
Correspondent Contact MARK N SMITH, P.E.
Regulation Number880.6860
Classification Product Code
MLR  
Date Received07/28/1994
Decision Date 08/02/1995
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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