510(k) K973293
K973293 is an FDA 510(k) premarket notification submitted by Vaughan Weeks for the device "SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR". The FDA issued a decision of Substantially Equivalent on November 18, 1997. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Vaughan Weeks has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1997
- Date Received
- September 2, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type