FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
K Number: K013337
·
Decision Dec 13, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
1
Review Days
65
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Basic Information
- Device Name
- PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
- K Number
- K013337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgin, Inc.
- Date Received
- October 9, 2001
- Decision Date
- December 13, 2001
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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