REFRESH CONTACTS LUBRICATING AND REWETTING DROPS— 510(k) K992028
Substantially EquivalentAllergan, Inc.
FDA 510(k) clearance K992028 for REFRESH CONTACTS LUBRICATING AND REWETTING DROPS, Substantially Equivalent on 1999-10-07. Applicant: Allergan, Inc.. Device class: 2.
Clearance details
- Applicant
- Allergan, Inc.
- Product code
- Code LPN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Irvine, CA, US
Recent devices under product code LPN
view allMore clearances from Allergan, Inc.
view allAdverse events under product code LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K992028
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992028.
Data sourced from openFDA. This site is unofficial and independent of the FDA.