FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO-PHACO HANDPIECE
K Number: K933503
·
Decision Jan 6, 1994
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
311
Applicant Total
6
Review Days
171
Basic Information
- Device Name
- PRO-PHACO HANDPIECE
- K Number
- K933503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- M. IMONTI AND ASSOCIATES INC.,
- Date Received
- July 19, 1993
- Decision Date
- January 6, 1994
- Product Code
- HQC
- 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | FDA class 2 | Ophthalmic |
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Other Clearances by M. IMONTI AND ASSOCIATES INC.,
| K Number | Device Name | ||
|---|---|---|---|
| K950800 | PRO-PAK FOR OMS DIPLOMATE | May 22, 1995 | Substantially Equivalent |
| K950799 | PRO-VIT | Apr 28, 1995 | Substantially Equivalent |
| K933627 | PHACOFRAGMENTOR TIP | Jan 25, 1994 | Substantially Equivalent |
| K924551 | ENDO TRACHEA TUBE FIXATION | Dec 8, 1992 | Substantially Equivalent |
| K905766 | DRAINAGE TUBE RESTRAINT/WOUND COVER | Mar 6, 1991 | Substantially Equivalent |