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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K895432
Device Name SAFE-T-CAP
Applicant
Ausmedics Pty , Ltd.
1120 G St. NW
Washington D.C.,  DC  20005
Applicant Contact PAUL M HYMAN
Correspondent
Ausmedics Pty , Ltd.
1120 G St. NW
Washington D.C.,  DC  20005
Correspondent Contact PAUL M HYMAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/08/1989
Decision Date 11/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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