FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFUSION CANNULA
K Number: K942403
·
Decision Aug 17, 1994
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- INFUSION CANNULA
- K Number
- K942403
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microsurgical Technology, Inc.
- Date Received
- May 19, 1994
- Decision Date
- August 17, 1994
- 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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Other Clearances by Microsurgical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953959 | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES | Nov 17, 1995 | Substantially Equivalent |
| K946194 | WEE BAG O'MERCURY | Feb 27, 1995 | Substantially Equivalent |
| K943672 | PHACO NEEDLES AND TIPS | Oct 13, 1994 | Substantially Equivalent |
| K934844 | INTER TIP T | Apr 19, 1994 | Substantially Equivalent |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | Dec 30, 1985 | Substantially Equivalent |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | Dec 30, 1985 | Substantially Equivalent |
| K853777 | THE NEW MCINTYRE CANNULA | Nov 21, 1985 | Substantially Equivalent |
| K840442 | STERILIZED DISPOS. CYSTOTOME | Mar 16, 1984 | Substantially Equivalent |