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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 K860688
Device Name MONOJECT PHARMACY TRAY
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact FUCILE, JR.
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact FUCILE, JR.
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/25/1986
Decision Date 08/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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