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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Syringe, Air And/Or Water
510(k) Number K931137
Device Name DENTAL SYRINGE TIP
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Applicant Contact MAT PARLIER
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Correspondent Contact MAT PARLIER
Regulation Number872.4565
Classification Product Code
ECB  
Date Received03/05/1993
Decision Date 11/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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