ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
FDA 510(k) clearance K983160 · decided 1999-02-18
Clearance details
- K-number
- K983160
- Device name
- ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
- Applicant
- Hydron , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-09
- Decision date
- 1999-02-18
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Farnborough, Hants, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.