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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Filter, Infusion Line
510(k) Number K790879
Device Name ULTIPOR SOLUTION CONTAINER FILTER
Applicant
Pall Biomedical Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pall Biomedical Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPB  
Date Received05/07/1979
Decision Date 06/01/1979
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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