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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Restorative And Impression Material
510(k) Number K851386
Device Name UNITEK DISPOSABLE IMPRESSION SYRINGE
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact LAWRENCE STEVENS
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact LAWRENCE STEVENS
Regulation Number872.4565
Classification Product Code
EID  
Date Received04/09/1985
Decision Date 04/29/1985
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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