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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K033381
Device Name DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
Applicant
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Applicant Contact STEVEN L ZIEMBA
Correspondent
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Correspondent Contact STEVEN L ZIEMBA
Regulation Number880.6885
Classification Product Code
MED  
Date Received10/22/2003
Decision Date 01/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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