FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SIALOGRAPHY NEEDLE
K Number: K831666
·
Decision Jul 12, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
50
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Basic Information
- Device Name
- SIALOGRAPHY NEEDLE
- K Number
- K831666
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Vertex Medical Corp.
- Date Received
- May 23, 1983
- Decision Date
- July 12, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K830576 | LYMPHANGIOGRAPHY SET | Mar 17, 1983 | Substantially Equivalent |
| K830420 | POLYETHYLENE MONITORING CONNECTORS | Feb 28, 1983 | Substantially Equivalent |
| K830237 | TRANSLUCENT POLY. CATH. CONNECTOR AND | Feb 18, 1983 | Substantially Equivalent |
| K823192 | TUOHY-BORST ADAPTER W/SIDE ARM | Dec 30, 1982 | Substantially Equivalent |
| K823253 | VERTEX MONITORING CATHETER | Dec 30, 1982 | Substantially Equivalent |
| K823256 | ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE | Dec 30, 1982 | Substantially Equivalent |
| K823254 | REUSABLE METAL STOPCOCK | Dec 30, 1982 | Substantially Equivalent |