NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
FDA 510(k) clearance K955900 · decided 1996-03-25
Clearance details
- K-number
- K955900
- Device name
- NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
- Applicant
- Novavision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-29
- Decision date
- 1996-03-25
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Novavision
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.