FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL HEADLIGHT
K Number: K842515
·
Decision Aug 2, 1984
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
9
Applicant Total
3
Review Days
51
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Basic Information
- Device Name
- SURGICAL HEADLIGHT
- K Number
- K842515
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Good-Lite Co.
- Date Received
- June 12, 1984
- Decision Date
- August 2, 1984
- Product Code
- EBA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EBA | Light, Surgical Headlight | FDA class 1 | Dental |
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