FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MIRROR WARMER
K Number: K781750
·
Decision Jan 17, 1979
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
8
Applicant Total
1
Review Days
93
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Basic Information
- Device Name
- MIRROR WARMER
- K Number
- K781750
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Arleton Technical Products, Inc.
- Date Received
- October 16, 1978
- Decision Date
- January 17, 1979
- Product Code
- KAI
- 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 |
|---|---|---|---|
| KAI | Mirror, Ent | FDA class 1 | Ear, Nose, Throat |
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