510(k) K946357
K946357 is an FDA 510(k) premarket notification submitted by Oasis Medical, Inc. for the device "COLLAGEN INTRACANALICULAR PLUG". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code LZU (Plug, Punctum), a Class U device. Oasis Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1995
- Date Received
- December 30, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plug, Punctum
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type