FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INVOTEC EAR TAMPON (WICK) W/STRING
K Number: K973578
·
Decision Nov 6, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
3
Applicant Total
16
Review Days
48
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Basic Information
- Device Name
- INVOTEC EAR TAMPON (WICK) W/STRING
- K Number
- K973578
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Invotec International, Inc.
- Date Received
- September 19, 1997
- Decision Date
- November 6, 1997
- Product Code
- KCN
- 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 |
|---|---|---|---|
| KCN | Ear Wick | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCN), ordered by most recent decision date.
NASOPORE EAR, MODELS ND04, ND05
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ULTRACELL EAR WICK
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
POPE OTO-WICK, STERILE & NON-STERILE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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