FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K Number: K022723
·
Decision Dec 26, 2002
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
1
Review Days
132
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Basic Information
- Device Name
- MASTEL 1 FOLDER IMPLANTATION SYSTEM
- K Number
- K022723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mastel Precision, Inc.
- Date Received
- August 16, 2002
- Decision Date
- December 26, 2002
- Product Code
- KYB
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
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