FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REMOVER, SOFT-SERT CONTACT LENS
K Number: K782140
·
Decision Feb 12, 1979
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
1
Review Days
47
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Basic Information
- Device Name
- REMOVER, SOFT-SERT CONTACT LENS
- K Number
- K782140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5420
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Mcmurray and Pendergost
- Date Received
- December 27, 1978
- Decision Date
- February 12, 1979
- 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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