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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 K893886
Device Name MITEK STERILIZATION TRAY
Applicant
Mitek Surgical Products, Inc.
990 Washington St.
Dedham,  MA  02026
Applicant Contact Robert Zoletti
Correspondent
Mitek Surgical Products, Inc.
990 Washington St.
Dedham,  MA  02026
Correspondent Contact Robert Zoletti
Regulation Number880.6880
Classification Product Code
FLE  
Date Received05/30/1989
Decision Date 08/21/1989
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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