FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEBESTYEN IRRIGATING CONTACT LENS
K Number: K802927
·
Decision Feb 5, 1981
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
7
Applicant Total
7
Review Days
78
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Basic Information
- Device Name
- SEBESTYEN IRRIGATING CONTACT LENS
- K Number
- K802927
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1395
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Cooper Medical Devices Corp.
- Date Received
- November 19, 1980
- Decision Date
- February 5, 1981
- Product Code
- HJI
- 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 |
|---|---|---|---|
| HJI | Lens, Fundus, Hruby, Diagnostic | FDA class 1 | Ophthalmic |
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FDA 510(k)
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Other Clearances by Cooper Medical Devices Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K802971 | LANDERS CONTACT LENS | Feb 5, 1981 | Substantially Equivalent |
| K801850 | CHARLES PNEUMATIC INTRAOCULAR SCISSORS | Sep 16, 1980 | Substantially Equivalent |
| K801411 | MAY ILLUMINATED/INFUSION PIC | Jul 21, 1980 | Substantially Equivalent |
| K801312 | THE PROTECTORS | Jun 17, 1980 | Substantially Equivalent |
| K800833 | VABRA ASPIRATOR | May 14, 1980 | Substantially Equivalent |
| K791898 | OCUTOME MODEL 8000 | Oct 30, 1979 | Substantially Equivalent |