510(k) K920170
K920170 is an FDA 510(k) premarket notification submitted by Sciara Intl., Inc. for the device "SPECTACLE FRAME". The FDA issued a decision of Substantially Equivalent on Mar 11, 1992. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 1992
- Date Received
- Jan 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Frame, Spectacle
- Device Class
- Class I
- Regulation Number
- 886.5842
- Review Panel
- OP
- Submission Type
- 510(k) Exempt