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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 K922522
Device Name MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
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 Received05/28/1992
Decision Date 11/25/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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