FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOMATED CORNEAL TREPHINE
K Number: K981063
·
Decision Jun 23, 1998
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
2
Review Days
92
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Basic Information
- Device Name
- AUTOMATED CORNEAL TREPHINE
- K Number
- K981063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4070
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laser Center Dev. Corp.
- Date Received
- March 23, 1998
- Decision Date
- June 23, 1998
- Product Code
- HRG
- 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 |
|---|---|---|---|
| HRG | Engine, Trephine, Accessories, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Laser Center Dev. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981235 | OCULOSTAT | Jul 15, 1998 | Substantially Equivalent |