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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 K843264
Device Name MONOJECT MENGHINI SOFT TISSUE BIOPSY
Applicant
Sherwood Medical Co.
1831 Olive St.
St. Louis,  MS  63103
Applicant Contact FRANK J FUCILE
Correspondent
Sherwood Medical Co.
1831 Olive St.
St. Louis,  MS  63103
Correspondent Contact FRANK J FUCILE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/20/1984
Decision Date 12/17/1984
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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