FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCLARENT SE Inflation Device
K Number: K150172
·
Decision Apr 7, 2015
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
64
Applicant Total
31
Review Days
71
Basic Information
- Device Name
- ACCLARENT SE Inflation Device
- K Number
- K150172
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACCLARENT, INC.
- Date Received
- January 26, 2015
- Decision Date
- April 7, 2015
- Product Code
- LRC
- 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 |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
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