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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 K896161
Device Name AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
Applicant
3M Company
1120 Red Fox Rd.
St. Paul,  MN  55112
Applicant Contact VON BUSCH
Correspondent
3M Company
1120 Red Fox Rd.
St. Paul,  MN  55112
Correspondent Contact VON BUSCH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/24/1989
Decision Date 01/11/1990
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
Recalls CDRH Recalls
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