SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)
FDA 510(k) clearance K963488 · decided 1996-11-20
Clearance details
- K-number
- K963488
- Device name
- SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)
- Applicant
- Specialty Ultravision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-03
- Decision date
- 1996-11-20
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Campbell, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.