FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K Number: K041381
·
Decision Sep 10, 2004
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
37
Review Days
108
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Basic Information
- Device Name
- MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
- K Number
- K041381
- 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
- Medtronic Xomed, Inc.
- Date Received
- May 25, 2004
- Decision Date
- September 10, 2004
- 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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