FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
K Number: K830871
·
Decision Jun 2, 1983
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
1
Applicant Total
5
Review Days
76
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Basic Information
- Device Name
- PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
- K Number
- K830871
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Phakosystems, Inc.
- Date Received
- March 18, 1983
- Decision Date
- June 2, 1983
- Product Code
- HOC
- 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 |
|---|---|---|---|
| HOC | Clip, Iris Retractor | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOC), ordered by most recent decision date.
View allOther Clearances by Phakosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880081 | VISION CARE/PHAKOSYSTEMS ECHOPACH | Mar 15, 1988 | Substantially Equivalent |
| K871938 | VISION CARE/PHAKOSYSTEMS ECHORULE | Nov 23, 1987 | Substantially Equivalent |
| K860236 | PHAKOSYSTEMS CT-100 CAUTERY MODULE | Feb 19, 1986 | Substantially Equivalent |
| K851674 | PHAKOSYSTEMS MODEL CES 4100 | Aug 5, 1985 | Substantially Equivalent |