FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CO2 MICROSURGICAL LASER SYSTEM #370
K Number: K802034
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
23
Applicant Total
3
Review Days
49
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Basic Information
- Device Name
- CO2 MICROSURGICAL LASER SYSTEM #370
- K Number
- K802034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Metricon, Ltd.
- Date Received
- August 22, 1980
- Decision Date
- October 10, 1980
- 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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