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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 K041084
Device Name CLIP-ON SPACER 20%; 40%; 50%
Applicant
SERONO, INC.
ONE TECHNOLOGY PLACE
ROCKLAND,  MA  02370
Applicant Contact PAMELA WILLIAMSON JOYCE
Correspondent
SERONO, INC.
ONE TECHNOLOGY PLACE
ROCKLAND,  MA  02370
Correspondent Contact PAMELA WILLIAMSON JOYCE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/26/2004
Decision Date 07/15/2004
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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