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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K883014
Device Name MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact CYNTHIA PESTKA
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact CYNTHIA PESTKA
Regulation Number878.4800
Classification Product Code
GAA  
Date Received07/19/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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