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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K832578
Device Name MONOJET SAMPLETTE ADAPTERS
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 Number864.6150
Classification Product Code
GIO  
Date Received08/02/1983
Decision Date 08/31/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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