FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL INSTRUMENTS
K Number: K820621
·
Decision Mar 19, 1982
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
3
Review Days
11
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Basic Information
- Device Name
- NASAL INSTRUMENTS
- K Number
- K820621
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Applied Fiberoptics, Inc.
- Date Received
- March 8, 1982
- Decision Date
- March 19, 1982
- Product Code
- EQH
- 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | FDA class 1 | Ear, Nose, Throat |
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