FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOLOS EYESITE CANNULAS
K Number: K872610
·
Decision Jul 31, 1987
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
5
Review Days
25
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Basic Information
- Device Name
- SOLOS EYESITE CANNULAS
- K Number
- K872610
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Solos Ophthalmology
- Date Received
- July 6, 1987
- Decision Date
- July 31, 1987
- 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 |
Similar 510(k) Clearances
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Other Clearances by Solos Ophthalmology
| K Number | Device Name | ||
|---|---|---|---|
| K874334 | SOLOS SINGLE USE TITANIUM TIP | Jan 11, 1988 | Substantially Equivalent |
| K872611 | SOLOS EYESITE CAP SLEEVE | Aug 10, 1987 | Substantially Equivalent |
| K872612 | SOLOS EYESITE SPONGES | Jul 31, 1987 | Substantially Equivalent |
| K872620 | SOLOS EYESITE DRAPES | Jul 31, 1987 | Substantially Equivalent |