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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K032757
Device Name A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Applicant Contact TOM LOUISELL
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Correspondent Contact TOM LOUISELL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/05/2003
Decision Date 12/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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