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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Transfer (Blood/Plasma)
510(k) Number K791131
Device Name FLU VEN TR-1
Applicant
Venospital, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Venospital, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.9875
Classification Product Code
KSB  
Date Received06/18/1979
Decision Date 09/04/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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