FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#157 EXAM LIGHT
K Number: K893949
·
Decision Aug 7, 1989
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
3
Review Days
67
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Basic Information
- Device Name
- #157 EXAM LIGHT
- K Number
- K893949
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medmark, Inc.
- Date Received
- June 1, 1989
- Decision Date
- August 7, 1989
- Product Code
- KFK
- 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 |
|---|---|---|---|
| KFK | Saw, Pneumatically Powered | FDA class 1 | General, Plastic Surgery |
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