FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NLD IMPLANT SET
K Number: K813314
·
Decision Feb 24, 1982
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
3
Review Days
92
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Basic Information
- Device Name
- NLD IMPLANT SET
- K Number
- K813314
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Design Research Assoc., Inc.
- Date Received
- November 24, 1981
- Decision Date
- February 24, 1982
- Product Code
- HMX
- 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | FDA class 1 | Ophthalmic |
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