FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KARICKHOFF FLYING CORPUSCLE VIEWER
K Number: K831829
·
Decision Oct 19, 1983
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
4
Review Days
134
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Basic Information
- Device Name
- KARICKHOFF FLYING CORPUSCLE VIEWER
- K Number
- K831829
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1435
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgidev Corp.
- Date Received
- June 7, 1983
- Decision Date
- October 19, 1983
- Product Code
- HIX
- 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 |
|---|---|---|---|
| HIX | Maxwell Spot, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
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