FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K Number: K844553
·
Decision Dec 11, 1984
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
152
Review Days
20
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Basic Information
- Device Name
- MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
- K Number
- K844553
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- November 21, 1984
- Decision Date
- December 11, 1984
- Product Code
- HNN
- 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | FDA class 1 | Ophthalmic |
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