FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCMD KERATOME
K Number: K935342
·
Decision Apr 1, 1994
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
1
Review Days
147
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Basic Information
- Device Name
- SCMD KERATOME
- K Number
- K935342
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S.C.M.D. Keratomes of Arizona
- Date Received
- November 5, 1993
- Decision Date
- April 1, 1994
- 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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