HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
FDA 510(k) clearance K020608 · decided 2002-05-16
Clearance details
- K-number
- K020608
- Device name
- HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
- Applicant
- Poly Vue Technolgies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-25
- Decision date
- 2002-05-16
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.