FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CILAS MODEL YM101
K Number: K852761
·
Decision Nov 14, 1985
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
18
Applicant Total
3
Review Days
139
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Basic Information
- Device Name
- CILAS MODEL YM101
- K Number
- K852761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Inframed, Inc.
- Date Received
- June 28, 1985
- Decision Date
- November 14, 1985
- Product Code
- LLO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | FDA class 2 | Ear, Nose, Throat |
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