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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Dental
510(k) Number K896219
Device Name SAFE-T-CAP NEEDLE COVER
Applicant
Ausmedics Pty , Ltd.
1120 G. St. NW
Washington,  DC  20005
Applicant Contact PAUL M HYMAN
Correspondent
Ausmedics Pty , Ltd.
1120 G. St. NW
Washington,  DC  20005
Correspondent Contact PAUL M HYMAN
Regulation Number872.4730
Classification Product Code
DZM  
Date Received10/27/1989
Decision Date 01/22/1990
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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