FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MICRO SYRINGE & NEEDLE
K Number: K771454
·
Decision Aug 16, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
31
Review Days
12
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Basic Information
- Device Name
- MICRO SYRINGE & NEEDLE
- K Number
- K771454
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Terumo America, Inc.
- Date Received
- August 4, 1977
- Decision Date
- August 16, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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| K Number | Device Name | ||
|---|---|---|---|
| K811523 | PLASMA FLEX | Sep 9, 1981 | Substantially Equivalent |
| K802970 | TERUMO HOLLOW FIBER OXYGENATOR | Jan 22, 1981 | Substantially Equivalent |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K791411 | COAXIAL DUAL FLOW CATHETER | Nov 13, 1979 | Substantially Equivalent |
| K791173 | SURFLO INJECTION PLUG | Jul 30, 1979 | Substantially Equivalent |
| K790105 | TERUMO IMUGARD | May 24, 1979 | Substantially Equivalent |