FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISC X-VITREOUS ASPIRATING & CUT. INSTR
K Number: K760684
·
Decision Oct 5, 1976
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
86
Review Days
15
Basic Information
- Device Name
- VISC X-VITREOUS ASPIRATING & CUT. INSTR
- K Number
- K760684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- VARIAN ASSOC., INC.
- Date Received
- September 20, 1976
- Decision Date
- October 5, 1976
- 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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|---|---|---|---|
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| K992751 | SOMAVISION | Feb 16, 2000 | Substantially Equivalent |
| K992753 | CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM | Sep 3, 1999 | Substantially Equivalent |
| K990085 | MILLENNIUM MLC -120 | Feb 8, 1999 | Substantially Equivalent |
| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | Oct 21, 1998 | Substantially Equivalent |
| K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Jul 26, 1996 | Substantially Equivalent |
| K955774 | VARIS PORTALVISION | Mar 15, 1996 | Substantially Equivalent |
| K954467 | CADPLAN BT | Mar 15, 1996 | Substantially Equivalent |
| K943224 | VARIAN MULTILEAF COLLIMATOR | Feb 2, 1996 | Substantially Equivalent |