FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
K Number: K042610
·
Decision May 16, 2005
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
1
Review Days
234
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Basic Information
- Device Name
- DR. THEISS ALERGOL POLLEN BLOCKER CREAM
- K Number
- K042610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5045
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dr. Theiss Naturwaren GmbH
- Date Received
- September 24, 2004
- Decision Date
- May 16, 2005
- Product Code
- NUP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUP | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | FDA class 2 | General Hospital |
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