510(k) K003109
K003109 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "COMPLETE BRAND LUBRICATING AND REWETTING DROPS". The FDA issued a decision of Substantially Equivalent on November 21, 2000. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Allergan, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2000
- Date Received
- October 4, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Soft Lens Products
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type