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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K853152
Device Name MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
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 Number862.1675
Classification Product Code
JKA  
Date Received07/29/1985
Decision Date 08/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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