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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 K852544
Device Name MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Applicant Contact FRANK J FUCILE
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Correspondent Contact FRANK J FUCILE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/14/1985
Decision Date 07/23/1985
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
Recalls CDRH Recalls
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