FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENT PACKINGS, WICKS, WIPES, AND SPONGES
K Number: K954449
·
Decision Nov 14, 1995
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
2
Review Days
81
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Basic Information
- Device Name
- ENT PACKINGS, WICKS, WIPES, AND SPONGES
- K Number
- K954449
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oasis
- Date Received
- August 25, 1995
- Decision Date
- November 14, 1995
- 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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Other Clearances by Oasis
| K Number | Device Name | ||
|---|---|---|---|
| K001464 | DISPOSABLE H-PE MICROKERATOME BLADES | Oct 2, 2000 | Substantially Equivalent |