FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBER OPTIC HEADLIGHT #60-0765
K Number: K802769
·
Decision Dec 11, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
55
Review Days
38
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Basic Information
- Device Name
- FIBER OPTIC HEADLIGHT #60-0765
- K Number
- K802769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4335
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Aspen Laboratories, Inc.
- Date Received
- November 3, 1980
- Decision Date
- December 11, 1980
- Product Code
- FCT
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| FCT | Headlight, Fiberoptic Focusing | FDA class 2 | Ophthalmic |
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