SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k) clearance K092852 · decided 2010-03-11
Clearance details
- K-number
- K092852
- Device name
- SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- Applicant
- St. shine Optical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-16
- Decision date
- 2010-03-11
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Taipei Hsien, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.