FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTACT LENS REMOVER AND INSERTER
K Number: K780663
·
Decision May 17, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- CONTACT LENS REMOVER AND INSERTER
- K Number
- K780663
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5420
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Dmv Contact Lens Co.
- Date Received
- April 20, 1978
- Decision Date
- May 17, 1978
- 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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