FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EAR KNIFE-VARIOUS
K Number: K841006
·
Decision May 30, 1984
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
6
Applicant Total
41
Review Days
82
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Basic Information
- Device Name
- EAR KNIFE-VARIOUS
- K Number
- K841006
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- March 9, 1984
- Decision Date
- May 30, 1984
- Product Code
- JYO
- 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 |
|---|---|---|---|
| JYO | Knife, Ear | FDA class 1 | Ear, Nose, Throat |
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