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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 K812748
Device Name MONOJECT M535 35CC SYRINGE
Applicant
SHERWOOD MEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHERWOOD MEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/29/1981
Decision Date 10/23/1981
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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