FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
K Number: K110687
·
Decision Oct 7, 2011
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
18
Applicant Total
31
Review Days
210
Basic Information
- Device Name
- RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
- K Number
- K110687
- 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
- March 11, 2011
- Decision Date
- October 7, 2011
- 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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| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | Feb 20, 2014 | Substantially Equivalent |
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