FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
KERATOPLASTY SUTURING LENS
K Number: K940106
·
Decision May 25, 1994
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
2
Review Days
135
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Basic Information
- Device Name
- KERATOPLASTY SUTURING LENS
- K Number
- K940106
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visionary Technologies of Miami, Inc.
- Date Received
- January 10, 1994
- Decision Date
- May 25, 1994
- Product Code
- HPX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | FDA unclassified | Unknown |
Similar 510(k) Clearances
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Other Clearances by Visionary Technologies of Miami, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940107 | VIRECTOMY LENS | Sep 6, 1994 | Substantially Equivalent |