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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 K033409
Device Name AMERSHAM HEALTH NEEDLE-GUARD
Applicant
Gettig Pharmaceutical Instrument Co.
1 Stream Side Pl. W.
P.O. Box 85
Spring Mills,  PA  16875 -0085
Applicant Contact JAMES A BENZ
Correspondent
Gettig Pharmaceutical Instrument Co.
1 Stream Side Pl. W.
P.O. Box 85
Spring Mills,  PA  16875 -0085
Correspondent Contact JAMES A BENZ
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/24/2003
Decision Date 01/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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