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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 K781815
Device Name HEMO-NATE SYRINGE BLOOD FILTER
Applicant
GISCO INTL.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GISCO INTL.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPB  
Date Received10/24/1978
Decision Date 02/27/1979
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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