FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHIN-UP STRIP
K Number: K040491
·
Decision Sep 10, 2004
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
19
Applicant Total
1
Review Days
197
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Basic Information
- Device Name
- CHIN-UP STRIP
- K Number
- K040491
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 874.3900
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dale Miller, Inc. - the Chin-Up Company
- Date Received
- February 26, 2004
- Decision Date
- September 10, 2004
- Product Code
- LWF
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| LWF | Dilator, Nasal | FDA class 1 | Ear, Nose, Throat |
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