FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OPTHALMIC ENDOSCOPE
K Number: K832405
·
Decision Nov 21, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
123
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Basic Information
- Device Name
- OPTHALMIC ENDOSCOPE
- K Number
- K832405
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cilco, Inc.
- Date Received
- July 21, 1983
- Decision Date
- November 21, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
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 |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | Nov 21, 1984 | 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 |
| K827371 | CILCO ASCAN | Jul 9, 1982 | Substantially Equivalent |
| K820933 | CILCO I/A HANDPIECE | Jun 14, 1982 | Substantially Equivalent |