510(k) K042610
- Device
- DR. THEISS ALERGOL POLLEN BLOCKER CREAM
- Applicant
- DR. THEISS NATURWAREN GMBH
- 510(k) number
- K042610
- Product code
- NUP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-05-16
- Date received
- 2004-09-24
- Regulation
- 880.5045
- Classification name
- Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
- Medical specialty
- General Hospital
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STUART PORTNOY
- Address
- 815 Connecticut Ave., NW Suite 800 Washington DC US 20006 20006
FDA Registration Numbers#
- 3011788145
- 3013037032
- 3010053755
- 3000241849
- 2214133
Source Documents#
Other 510(k) Records For Product Code NUP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | 2022-06-24 |
| K201734 | AllerBlock Junior | Nasaleze International, Ltd. | 2021-03-26 |
| K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | 2017-06-14 |
| K134003 | RHINIX NASAL FILTER | Rhinix Aps | 2014-09-04 |
| K132520 | NASAL EASE ALLERGY BLOCKER | Hi-Tech Pharmacal, Inc. | 2013-12-31 |
| K120894 | HAYMAX | Haymax Limited | 2012-05-17 |
| K053625 | NASALGUARD | Trutek Corp | 2006-02-22 |
Legacy Summary#
summary
FDA Review#
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