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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 K823176
Device Name MONOJECT SAMPLETTE CAPILLARY SERUM SEP
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 Number862.1675
Classification Product Code
JKA  
Date Received10/26/1982
Decision Date 11/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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