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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Dry Heat
510(k) Number K880322
Device Name DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
Applicant
Dentronix, Inc.
101 Steamwhistle Dr.
Ivyland,  PA  18974
Applicant Contact PETER O SILDVE
Correspondent
Dentronix, Inc.
101 Steamwhistle Dr.
Ivyland,  PA  18974
Correspondent Contact PETER O SILDVE
Regulation Number880.6870
Classification Product Code
KMH  
Date Received01/27/1988
Decision Date 07/13/1988
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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