FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
K Number: K901002
·
Decision May 22, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
15
Applicant Total
12
Review Days
81
Basic Information
- Device Name
- O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
- K Number
- K901002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3340
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- OCULO PLASTIK, INC.
- Date Received
- March 2, 1990
- Decision Date
- May 22, 1990
- Product Code
- HQX
- 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 |
|---|---|---|---|
| HQX | Implant, Orbital, Extra-Ocular | FDA class 2 | Ophthalmic |
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Other Clearances by OCULO PLASTIK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K112176 | SILICONE SPHERES | Sep 15, 2011 | Substantially Equivalent |
| K073293 | DURETTE IMPLANT | Mar 19, 2008 | Substantially Equivalent |
| K040689 | EYE SPHERE IMPLANTS | Jun 10, 2004 | Substantially Equivalent |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | May 5, 1994 | Substantially Equivalent |
| K915630 | OPHTIMPLANT | Mar 2, 1992 | Substantially Equivalent |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | May 18, 1990 | Substantially Equivalent |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | May 15, 1990 | Substantially Equivalent |
| K900928 | COX MALAR EMINENCE IMPLANTS | May 15, 1990 | Substantially Equivalent |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | May 15, 1990 | Substantially Equivalent |
| K900080 | NEW IOWA MOTILITY IMPLANT | Mar 23, 1990 | Substantially Equivalent |