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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tube, Aspirating, Flexible, Connecting
510(k) Number K820371
Device Name PLASTIC CONNECTORS
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 Number880.6740
Classification Product Code
BYY  
Date Received02/09/1982
Decision Date 04/01/1982
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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