FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTACT LENS TWEEZERS
K Number: K871130
·
Decision May 12, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
2
Review Days
53
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Basic Information
- Device Name
- CONTACT LENS TWEEZERS
- K Number
- K871130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5420
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- S. M. C. Medi-Tech Corp.
- Date Received
- March 20, 1987
- Decision Date
- May 12, 1987
- Product Code
- KYE
- 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 |
|---|---|---|---|
| KYE | Inserter/Remover Contact Lens | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYE), ordered by most recent decision date.
SOFT CONTACT LENS REMOVER
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HARD CONTACT LENS REMOVER. ITEM #289
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MARLIN SOFT LENS TWEEZER
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MARLIN SOFT LENS HANDLER
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LENSERT CONTACT LENS CLEANING & INSERT
FDA 510(k)
FDA Class 1
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Other Clearances by S. M. C. Medi-Tech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K863846 | CONTAC CASE | Apr 6, 1987 | Substantially Equivalent |