FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CILCOR OPHTHALMIC INSTRUMENTS
K Number: K843992
·
Decision Nov 21, 1984
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
12
Review Days
41
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Basic Information
- Device Name
- CILCOR OPHTHALMIC INSTRUMENTS
- K Number
- K843992
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Cilco, Inc.
- Date Received
- October 11, 1984
- Decision Date
- November 21, 1984
- Product Code
- HNR
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Cilco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | May 2, 1986 | Substantially Equivalent |
| K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) | Feb 27, 1986 | Substantially Equivalent |
| K844249 | K-SOL | Apr 30, 1985 | Substantially Equivalent |
| K843319 | CILCO I/A SURGICAL PACK | Feb 14, 1985 | Substantially Equivalent |
| K843447 | CILCO DIAMOND KNIFE | Oct 5, 1984 | Substantially Equivalent |
| K841099 | OCTOPUS 500/500E | Jun 19, 1984 | Substantially Equivalent |
| K840475 | CYSTOTOME, 140-S | Apr 5, 1984 | Substantially Equivalent |
| K832405 | OPTHALMIC ENDOSCOPE | Nov 21, 1983 | Substantially Equivalent |
| K827371 | CILCO ASCAN | Jul 9, 1982 | Substantially Equivalent |
| K820933 | CILCO I/A HANDPIECE | Jun 14, 1982 | Substantially Equivalent |