The following data is part of a premarket notification filed by Dr. Theiss Naturwaren Gmbh with the FDA for Dr. Theiss Alergol Pollen Blocker Cream.
| Device ID | K042610 |
| 510k Number | K042610 |
| Device Name: | DR. THEISS ALERGOL POLLEN BLOCKER CREAM |
| Classification | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Applicant | DR. THEISS NATURWAREN GMBH 815 CONNECTICUT AVE., NW SUITE 800 Washington, DC 20006 |
| Contact | Stuart Portnoy |
| Correspondent | Stuart Portnoy DR. THEISS NATURWAREN GMBH 815 CONNECTICUT AVE., NW SUITE 800 Washington, DC 20006 |
| Product Code | NUP |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2005-05-16 |
| Summary: | summary |