510(k) K852548
K852548 is an FDA 510(k) premarket notification submitted by Ascon Medical Instruments, Ltd. for the device "ATL 225 MW TRAIL LENS SET". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code HPA (Frame, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1415. Ascon Medical Instruments, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1985
- Date Received
- June 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Frame, Trial, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1415
- Review Panel
- OP
- Submission Type