FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCLERAL POWDER
K Number: K791923
·
Decision Jan 10, 1980
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
5
Applicant Total
1
Review Days
106
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Basic Information
- Device Name
- SCLERAL POWDER
- K Number
- K791923
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.3200
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ocularists , Ltd.
- Date Received
- September 26, 1979
- Decision Date
- January 10, 1980
- Product Code
- HQH
- 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 |
|---|---|---|---|
| HQH | Eye, Artificial, Non-Custom | FDA class 1 | Ophthalmic |
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