510(k) K833669
K833669 is an FDA 510(k) premarket notification submitted by Michael Onufryk for the device "IMAGE DEFLECTOR". The FDA issued a decision of Substantially Equivalent on March 27, 1984. The device falls under product code HPA (Frame, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1415.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1984
- Date Received
- October 18, 1983
- 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