FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BENSON CCA100
K Number: K924652
·
Decision Apr 9, 1993
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
23
Applicant Total
5
Review Days
206
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Basic Information
- Device Name
- BENSON CCA100
- K Number
- K924652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Benson Medical Instruments Co.
- Date Received
- September 15, 1992
- Decision Date
- April 9, 1993
- Product Code
- EWG
- 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 |
|---|---|---|---|
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | FDA class 2 | Ear, Nose, Throat |
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