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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K832284
Device Name SOLUTION ADMIN. SET 2C9096 W/10 PVC
Applicant
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/13/1983
Decision Date 12/29/1983
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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