FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLEAR-VIEW MIRROR WARMER
K Number: K800382
·
Decision May 14, 1980
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
22
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- CLEAR-VIEW MIRROR WARMER
- K Number
- K800382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgical Mechanical Research, Inc.
- Date Received
- February 22, 1980
- Decision Date
- May 14, 1980
- Product Code
- GET
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | FDA class 1 | General, Plastic Surgery |
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