510(k) K032283
K032283 is an FDA 510(k) premarket notification submitted by Designs For Vision, Inc. for the device "DESIGNS FOR VISION FIBEROPTIC LIGHT". The FDA issued a decision of Substantially Equivalent on August 20, 2003. The device falls under product code GDB (Endoscope, Fiber Optic), a Class II device regulated under 21 CFR 876.1500. Designs For Vision, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2003
- Date Received
- July 24, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Fiber Optic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type