FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SINUFLUSH LAVAGE SYSTEM
K Number: K131177
·
Decision Sep 20, 2013
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
2
Applicant Total
1
Review Days
148
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Basic Information
- Device Name
- SINUFLUSH LAVAGE SYSTEM
- K Number
- K131177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hedgepath, LLC
- Date Received
- April 25, 2013
- Decision Date
- September 20, 2013
- Product Code
- KAR
- 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 |
|---|---|---|---|
| KAR | Irrigator, Sinus | FDA class 1 | Ear, Nose, Throat |
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