510(k) K945350
K945350 is an FDA 510(k) premarket notification submitted by Taiwan Eva Industrial Co., Inc. for the device "FRAME, SPECTACLES". The FDA issued a decision of Substantially Equivalent on Dec 13, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Taiwan Eva Industrial Co., Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 1994
- Date Received
- Sep 14, 1994
- 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