FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
K Number: K012435
·
Decision Oct 2, 2001
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
0
Applicant Total
92
Review Days
63
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Basic Information
- Device Name
- ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
- K Number
- K012435
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- July 31, 2001
- Decision Date
- October 2, 2001
- Product Code
- NGY
- 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 |
|---|---|---|---|
| NGY | Cannula, Trocar, Ophthalmic | FDA class 1 | Ophthalmic |
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