510(k) K801058
K801058 is an FDA 510(k) premarket notification submitted by Designs For Vision, Inc. for the device "ILLUMINATED SPECULUM". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code FXF (Speculum, Illuminated), a Class I device regulated under 21 CFR 878.1800. Designs For Vision, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1980
- Date Received
- May 6, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Illuminated
- Device Class
- Class I
- Regulation Number
- 878.1800
- Review Panel
- SU
- Submission Type