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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
510(k) Number K042610
Device Name DR. THEISS ALERGOL POLLEN BLOCKER CREAM
Applicant
Dr. Theiss Naturwaren GmbH
815 Connecticut Ave., NW
Suite 800
Washington,  DC  20006
Applicant Contact STUART PORTNOY
Correspondent
Dr. Theiss Naturwaren GmbH
815 Connecticut Ave., NW
Suite 800
Washington,  DC  20006
Correspondent Contact STUART PORTNOY
Regulation Number880.5045
Classification Product Code
NUP  
Date Received09/24/2004
Decision Date 05/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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