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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K950309
Device Name EAGLE
Applicant
Aalba Dent, Inc.
400 Watt Dr.
Fairfield,  CA  94534
Applicant Contact VINCENT BENETTI
Correspondent
Aalba Dent, Inc.
400 Watt Dr.
Fairfield,  CA  94534
Correspondent Contact VINCENT BENETTI
Regulation Number872.6770
Classification Product Code
EJI  
Date Received01/25/1995
Decision Date 02/16/1995
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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