FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLADEWORKS DISPOSABLE ALK TUBING
K Number: K993591
·
Decision Dec 28, 1999
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
3
Review Days
67
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Basic Information
- Device Name
- BLADEWORKS DISPOSABLE ALK TUBING
- K Number
- K993591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Blade Works, Inc.
- Date Received
- October 22, 1999
- Decision Date
- December 28, 1999
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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