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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K973510
Device Name DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
Applicant
Immuno-U.S., Inc.
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Applicant Contact DAVID WEST
Correspondent
Immuno-U.S., Inc.
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Correspondent Contact DAVID WEST
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/16/1997
Decision Date 12/08/1997
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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