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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Trap, Sterile Specimen
510(k) Number K822557
Device Name SPECIMEN ADAPTOR
Applicant
BEMIS HEALTH CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BEMIS HEALTH CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6740
Classification Product Code
BYZ  
Date Received08/24/1982
Decision Date 10/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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