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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 K811773
Device Name BACTAGARD
Applicant
Tri-Med, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tri-Med, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPB  
Date Received06/22/1981
Decision Date 07/13/1981
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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