510(k) K841768
K841768 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN LIGHTWEIGHT TRIAL FRAME". The FDA issued a decision of Substantially Equivalent on June 1, 1984. The device falls under product code HPA (Frame, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1415. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1984
- Date Received
- April 27, 1984
- 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