510(k) K852126
K852126 is an FDA 510(k) premarket notification submitted by Ascon Medical Instruments, Ltd. for the device "ATF 101 TRAIL FRAME". The FDA issued a decision of Substantially Equivalent on June 5, 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
- June 5, 1985
- Date Received
- May 15, 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