FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OCUTOME PARATUBING SET
K Number: K832938
·
Decision Oct 19, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
47
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Basic Information
- Device Name
- OCUTOME PARATUBING SET
- K Number
- K832938
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Vxtra Corp.
- Date Received
- September 2, 1983
- Decision Date
- October 19, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Other Clearances by Vxtra Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832980 | VXTRA OCUTOME KIT | Oct 19, 1983 | Substantially Equivalent |
| K831266 | MICROSURGICAL KNIFE | Jun 10, 1983 | Substantially Equivalent |
| K830385 | IRRIGATION/ASPIRATION KIT | Apr 5, 1983 | Substantially Equivalent |
| K830379 | PHAKO KIT | Apr 5, 1983 | Substantially Equivalent |
| K812620 | ADJUSTABLE MICROSURGICAL KNIFE | Oct 19, 1981 | Substantially Equivalent |
| K812526 | MICRO BLADE II | Sep 16, 1981 | Substantially Equivalent |
| K812160 | MICROSURGICAL BLADE | Aug 31, 1981 | Substantially Equivalent |
| K800557 | DISPOSABLE PRE-GELLED ELECTROSURGICAL | Apr 21, 1980 | Substantially Equivalent |
| K792436 | VXTRA BACK PACK EKG ELECTRODE CAT. NO. | Feb 22, 1980 | Substantially Equivalent |