FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ML-DISPOSABLE PAK
K Number: K972522
·
Decision Sep 30, 1997
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
12
Review Days
85
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Basic Information
- Device Name
- ML-DISPOSABLE PAK
- K Number
- K972522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Logics, Inc.
- Date Received
- July 7, 1997
- Decision Date
- September 30, 1997
- Product Code
- MSR
- 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 |
|---|---|---|---|
| MSR | Tubing, Replacement, Phacofragmentation Unit | FDA class 2 | Ophthalmic |
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Other Clearances by Med-Logics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033293 | MED-LOGICS, MODEL ML7090 | Jan 13, 2004 | Substantially Equivalent |
| K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | Nov 15, 2002 | Substantially Equivalent |
| K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | Oct 11, 2002 | Substantially Equivalent |
| K010872 | ML BLADE, MODEL ML7030 | Jun 22, 2001 | Substantially Equivalent |
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | Apr 27, 2001 | Substantially Equivalent |
| K002515 | MEDLOGICS ML 4000, MODEL 4000 | Feb 22, 2001 | Substantially Equivalent |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | Aug 18, 2000 | Substantially Equivalent |
| K983448 | ML UNIVERSAL TUBING | Dec 18, 1998 | Substantially Equivalent |
| K981071 | ML MICROKERATOME | Jul 23, 1998 | Substantially Equivalent |
| K971173 | ML DISPOSABLE ALK TUBING | May 22, 1997 | Substantially Equivalent |