FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SNO STRIPS STERILE TEARFLOW TEST STRIP
K Number: K832181
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
2
Applicant Total
529
Review Days
37
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Basic Information
- Device Name
- SNO STRIPS STERILE TEARFLOW TEST STRIP
- K Number
- K832181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1800
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Smith & Nephew, Inc.
- Date Received
- July 6, 1983
- Decision Date
- August 12, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYD), ordered by most recent decision date.
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
TEAR VOLUME TESTS
FDA 510(k)
FDA Class 1
·Ophthalmic
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