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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen, Sterile
510(k) Number K802340
Device Name SPECIMEN SET
Applicant
American Pharmaseal Div. Ahsc
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Pharmaseal Div. Ahsc
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.3250
Classification Product Code
FMH  
Date Received09/26/1980
Decision Date 10/10/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
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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