FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMCENAN OCULAR EXPLANTS AND BANDS
K Number: K902308
·
Decision Jun 19, 1990
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- TAMCENAN OCULAR EXPLANTS AND BANDS
- K Number
- K902308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3340
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Tamcenan Corp.
- Date Received
- May 22, 1990
- Decision Date
- June 19, 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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