510(k) K874900
K874900 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN CLASSIC REFRACTOR, PHOROPTOR". The FDA issued a decision of Substantially Equivalent on December 23, 1987. The device falls under product code HKN (Refractor, Manual, Non-Powered, Including Phoropter), a Class I device regulated under 21 CFR 886.1770. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1987
- Date Received
- December 1, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Refractor, Manual, Non-Powered, Including Phoropter
- Device Class
- Class I
- Regulation Number
- 886.1770
- Review Panel
- OP
- Submission Type