FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
K Number: K130354
·
Decision May 29, 2013
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
4
Review Days
106
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Basic Information
- Device Name
- MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
- K Number
- K130354
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Entrigue Surgical, Inc.
- Date Received
- February 12, 2013
- Decision Date
- May 29, 2013
- Product Code
- LYA
- 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 |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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