FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KERATOME SYSTEM, MODEL K3000
K Number: K984537
·
Decision May 14, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
11
Applicant Total
2
Review Days
144
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Basic Information
- Device Name
- KERATOME SYSTEM, MODEL K3000
- K Number
- K984537
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Insight Technologies Instruments, LLC
- Date Received
- December 21, 1998
- Decision Date
- May 14, 1999
- Product Code
- HMY
- 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 |
|---|---|---|---|
| HMY | Keratome, Battery-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Insight Technologies Instruments, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K974243 | KERATOME SYSTEM | Jan 20, 1998 | Substantially Equivalent |