ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
FDA 510(k) clearance K980554 · decided 1998-04-07
Clearance details
- K-number
- K980554
- Device name
- ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
- Applicant
- Alden Optical Labs., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-13
- Decision date
- 1998-04-07
- Days to decision
- 53 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AL-47 SOFT CONTACT LENS (P820078) | Alden Optical Labs., Inc. | 1984-01-30 |