510(k) K140409
K140409 is an FDA 510(k) premarket notification submitted by Apothecary Products, Inc. for the device "FLENTS PLASTIC EYE WASH CUP". The FDA issued a decision of Substantially Equivalent on July 9, 2014. The device falls under product code LXQ (Cup, Eye), a Class U device. Apothecary Products, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2014
- Date Received
- February 18, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Eye
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type