FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LASER CENTERING DEVICE
K Number: K872747
·
Decision Sep 4, 1987
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
4
Applicant Total
3
Review Days
53
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Basic Information
- Device Name
- LASER CENTERING DEVICE
- K Number
- K872747
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Innomed Corp.
- Date Received
- July 13, 1987
- Decision Date
- September 4, 1987
- Product Code
- HMR
- 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 |
|---|---|---|---|
| HMR | Marker, Ocular | FDA class 1 | Ophthalmic |
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