FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARLIN SOFT LENS TWEEZER
K Number: K850983
·
Decision Sep 10, 1985
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
3
Review Days
183
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Basic Information
- Device Name
- MARLIN SOFT LENS TWEEZER
- K Number
- K850983
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5420
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Marlin Industries
- Date Received
- March 11, 1985
- Decision Date
- September 10, 1985
- 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 |
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