FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
K Number: K911734
·
Decision Nov 7, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
2
Applicant Total
1
Review Days
204
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Basic Information
- Device Name
- TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
- K Number
- K911734
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1800
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Northland Cataract & Eye Care Clinic
- Date Received
- April 17, 1991
- Decision Date
- November 7, 1991
- Product Code
- KYD
- 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 |
|---|---|---|---|
| KYD | Strip, Schirmer | FDA class 1 | Ophthalmic |
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