FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROMEDICS EAR, NOSE AND THROAT BURS
K Number: K895738
·
Decision Dec 19, 1989
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
17
Applicant Total
29
Review Days
84
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Basic Information
- Device Name
- MICROMEDICS EAR, NOSE AND THROAT BURS
- K Number
- K895738
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4140
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Micromedics, Inc.
- Date Received
- September 26, 1989
- Decision Date
- December 19, 1989
- Product Code
- EQJ
- 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 |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | FDA class 1 | Ear, Nose, Throat |
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