FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCUTOME MODEL 8000
K Number: K791898
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
7
Review Days
35
Basic Information
- Device Name
- OCUTOME MODEL 8000
- K Number
- K791898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- COOPER MEDICAL DEVICES CORP.
- Date Received
- September 25, 1979
- Decision Date
- October 30, 1979
- Product Code
- HKP
- 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 |
|---|---|---|---|
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by COOPER MEDICAL DEVICES CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K802971 | LANDERS CONTACT LENS | Feb 5, 1981 | Substantially Equivalent |
| K802927 | SEBESTYEN IRRIGATING 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 |