FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPHTHALMIC CANNULA
K Number: K881487
·
Decision Apr 29, 1988
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- OPHTHALMIC CANNULA
- K Number
- K881487
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgical Instrument, Inc.
- Date Received
- April 8, 1988
- Decision Date
- April 29, 1988
- 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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