FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFUSION CANNULA
K Number: K831192
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
22
Review Days
79
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Basic Information
- Device Name
- INFUSION CANNULA
- K Number
- K831192
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Instrument Development Laboratories, Inc.
- Date Received
- April 12, 1983
- Decision Date
- June 30, 1983
- Product Code
- HMX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | FDA class 1 | Ophthalmic |
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| K971067 | DIGI-INJECTOR | Sep 19, 1997 | Substantially Equivalent |
| K950287 | UNIVIT PROBE | Apr 10, 1995 | Substantially Equivalent |
| K934600 | MICRODRIVE | Jul 27, 1994 | Substantially Equivalent |
| K932669 | SUPRA-VIT(TM) | Jun 3, 1994 | Substantially Equivalent |
| K932131 | MID LABS TWIN ILLUMINATOR | Apr 1, 1994 | Substantially Equivalent |
| K924222 | MID LABS, INC. VIT MATE | Jan 27, 1993 | Substantially Equivalent |
| K851610 | COMBINED MVS SYSTEMS | Jul 22, 1985 | Substantially Equivalent |