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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K873465
Device Name VAN DELLEN BACTERIA FILTER
Applicant
Van Dellen, Ltd.
3810 E. 44th St., Suite 301
P.O. Box 27748
Tucson,  AZ  85726
Applicant Contact ROGER DANHOF
Correspondent
Van Dellen, Ltd.
3810 E. 44th St., Suite 301
P.O. Box 27748
Tucson,  AZ  85726
Correspondent Contact ROGER DANHOF
Regulation Number880.5440
Classification Product Code
FPK  
Date Received08/28/1987
Decision Date 01/20/1988
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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