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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name infusor, pressure, for i.v. bags
510(k) Number K760483
Device Name BLOOD-SOLUTION ADMINISTRATION SET, SURG.
Applicant
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5420
Classification Product Code
KZD  
Date Received08/20/1976
Decision Date 09/03/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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