FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I/A KIT
K Number: K831159
·
Decision Apr 28, 1983
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
22
Review Days
17
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Basic Information
- Device Name
- I/A KIT
- K Number
- K831159
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Staar Surgical Co.
- Date Received
- April 11, 1983
- Decision Date
- April 28, 1983
- Product Code
- JSM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Jun 10, 2004 | Substantially Equivalent |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | May 16, 2002 | Substantially Equivalent |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Dec 4, 1998 | Substantially Equivalent |
| K980696 | FOAM TIP INJECTOR | Sep 11, 1998 | Substantially Equivalent |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Dec 21, 1995 | Substantially Equivalent |
| K913626 | SOFTRANS INJECTOR | Dec 18, 1991 | Substantially Equivalent |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | Feb 17, 1989 | Substantially Equivalent |