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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K873462
Device Name VAN DELLEN ASPIRATOR
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 Number878.4780
Classification Product Code
BTA  
Date Received08/28/1987
Decision Date 09/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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