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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 K873569
Device Name BLOOD NEEDLE HOLDER
Applicant
SAGE PRODUCTS, INC.
680 INDUSTRIAL DR.
CARY,  IL  60013
Applicant Contact PAUL H HANIFL
Correspondent
SAGE PRODUCTS, INC.
680 INDUSTRIAL DR.
CARY,  IL  60013
Correspondent Contact PAUL H HANIFL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/02/1987
Decision Date 11/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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