FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WEE BAG O'MERCURY
K Number: K946194
·
Decision Feb 27, 1995
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
9
Review Days
69
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Basic Information
- Device Name
- WEE BAG O'MERCURY
- K Number
- K946194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4610
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microsurgical Technology, Inc.
- Date Received
- December 20, 1994
- Decision Date
- February 27, 1995
- Product Code
- LCC
- 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 |
|---|---|---|---|
| LCC | Applicator, Ocular Pressure | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCC), ordered by most recent decision date.
ILWAIT TIMER OCULOPRESSOR
FDA 510(k)
FDA Class 2
·Ophthalmic
OCULAR PRESSURE REDUCER (MCCANNEL)
FDA 510(k)
FDA Class 2
·Ophthalmic
WEE BAG O'MERCURY
FDA 510(k)
FDA Class 2
·Ophthalmic
RELIEF VALVE-HONAN INTRAOC. PRESSURE
FDA 510(k)
FDA Class 2
·Ophthalmic
NEVYAS AUTOPRESS EYE COMPRESSOR
FDA 510(k)
FDA Class 2
·Ophthalmic
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 |
| K943672 | PHACO NEEDLES AND TIPS | Oct 13, 1994 | Substantially Equivalent |
| K942403 | INFUSION CANNULA | Aug 17, 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 |