FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RELIENT NAVIGATION DEVICE
K Number: K060974
·
Decision May 5, 2006
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
18
Applicant Total
45
Review Days
25
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Basic Information
- Device Name
- RELIENT NAVIGATION DEVICE
- K Number
- K060974
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acclarent, Inc.
- Date Received
- April 10, 2006
- Decision Date
- May 5, 2006
- Product Code
- KAM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KAM | Cannula, Sinus | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KAM), ordered by most recent decision date.
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RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
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FDA Class 1
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